Orthosis, Spondylolisthesis Spinal Fixation

FDA product code MNH · 287 cleared devices

Class 2 Orthopedic

Regulation: 21 CFR 888.3070
Review panel: OR
Implant: Yes
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1995-01-20 – 2016-12-02

MNH 2000-01-13

SOCON SPINAL SYSTEM

Applicant Aesculap, Inc.

K number K993551

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MNH 1999-12-17

OMNIAXIAL CONNECTOR

Applicant Ortho Tec, LLC

K number K993926

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MNH 1999-12-06

SYNERGY INTEGRAL SCREWS, MODEL NUMBERS 2161,2162,2163,2164,2165,2166,2167,2168,2169,2210,2211,2212,2215,2216,2217,2220

Applicant Interpore Cross Intl.

K number K993808

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MNH 1999-09-14

DANEK PLATE AND SCREW SYSTEM

Applicant Sofamor Danek USA,Inc.

K number K991036

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MNH 1999-08-27

OSTEONICS SPINAL SYSTEM- ROD/ PLATE SYSTEM

Applicant Howmedica Osteonics Corp.

K number K991055

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MNH 1999-06-02

SYNTHES PEDIATRIC ROD SYSTEM

Applicant Synthes (Usa)

K number K991552

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MNH 1999-05-28

MODIFICATION TO TENOR SPINAL SYSTEM-ROD/BOLT CONNECTOR

Applicant Danek Medical, Inc.

K number K991528

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MNH 1999-05-27

ISOLOCK SPINAL SYSTEM

Applicant Scien'Tx USA, Inc.

K number K990721

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MNH 1999-05-19

MODIFICATION TO ZPLATE-ATL ANTERIOR FIXATION SYSTEM

Applicant Sofamor Danek

K number K991460

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MNH 1999-05-19

MODIFICATION TO TENOR SPINAL SYSTEM-PLATES

Applicant Sofamor Danek USA,Inc.

K number K991364

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MNH 1999-03-26

TRIFIX PEDICLE SPINAL SCREW ASSEMBLY

Applicant Corin USA

K number K990657

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MNH 1999-03-22

ISOBAR SPINAL SYSTEM

Applicant Scien'Tx USA, Inc.

K number K990118

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MNH 1998-12-18

OSTEONICS SPINAL SYSTEM CYLINDRICAL BONE SCREWS

Applicant Osteonics Corp.

K number K984302

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MNH 1998-09-25

OSTEONICS SPINAL SYSTEM 5.5MM & 10.0MM BONE SCREWS

Applicant Osteonics Corp.

K number K983152

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MNH 1998-08-04

SYNTHES SPINE PEDIATRIC ROD SYSTEM

Applicant Synthes Spine

K number K980761

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MNH 1998-06-30

TIMX LOW BACK SYSTEM TITANIUM MX ROD BASED LOW BACK SYSTEM

Applicant Acromed Corp.

K number K981714

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MNH 1998-05-29

PEDIATRIC PRC

Applicant Acromed Corp.

K number K981113

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MNH 1998-05-20

TITANIUM SPINAL ROD SYSTEM

Applicant United States Surgical, A Division of Tyco Healthc

K number K980862

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MNH 1998-05-01

GII SPINAL FIXATION SYSTEM

Applicant Karen E. Warden, M.E.B.E.

K number K980852

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MNH 1998-04-29

ACROMED TIMX PLATE BASED LOW BACK SYSTEM

Applicant Acromed Corp.

K number K981274

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MNH 1998-04-14

WRIGHT MEDICAL TECHNOLOGY ROD-TO-ROD COUPLER

Applicant Wrightmedicaltechnologyinc

K number K980496

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MNH 1998-04-14

DEPUY MOTECH MOSS MIAMI SPINAL SYSTEM

Applicant DePuy Orthopaedics, Inc.

K number K980447

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MNH 1998-03-18

SPINAL CONCEPTS, INC., BACFIX TI SPINAL FIXATION SYSTEM

Applicant Spinal Concepts, Inc.

K number K973687

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MNH 1998-03-13

SYNERGY CLOSED VARIABLE LOCKING SCREW (VLS), PART OF THE CROSS MEDICAL-SYNERGY ANTERIOR AND POSTERIOR SPINAL SYSTEMS

Applicant Cross Medical Products, Inc.

K number K974749

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MNH 1998-03-10

AURORA TITANIUM SPINAL ROD SYSTEM

Applicant United States Surgical, A Division of Tyco Healthc

K number K974734

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MNH 1998-03-05

SYNERGY 6.35MM SS ROD WITH SCREWS FOR ANTERIOR USE, PART OF THE CROSS MEDICAL-SYNERGY ANTERIOR SPINAL SYSTEM

Applicant Cross Medical Products, Inc.

K number K973836

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MNH 1998-02-27

THE MEHDIAN LUMBO-SACRAL PEDICLE SCREW SYSTEM

Applicant Corin USA

K number K973425

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MNH 1998-02-04

AURORA TITANIUM SPINAL ROD SYSTEM

Applicant United States Surgical, A Division of Tyco Healthc

K number K974213

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MNH 1997-12-24

OMEGA 21 SYSTEM

Applicant Ebi Electro Biology

K number K973683

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MNH 1997-09-19

DEPUY MOTECH MOSS-MIAMI SPINAL SYSTEM

Applicant Depuy, Inc.

K number K972568

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MNH 1997-08-20

EBI SPINELINK SYSTEM

Applicant Electro-Biology, Inc.

K number K971970

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MNH 1997-06-25

AESUCLAP SOCON SPINAL SYSTEM

Applicant Aesculap, Inc.

K number K970285

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MNH 1997-06-03

EASY ROD

Applicant Acromed Corp.

K number K970950

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MNH 1997-05-08

ACROMED PEDICLE SCREW

Applicant Acromed Corp.

K number K965102

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MNH 1997-04-09

EBI SPINELINK SYSTEM

Applicant Electro-Biology, Inc.

K number K964533

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MNH 1997-03-14

ISOLA TWISTER CONNECTOR

Applicant Acromed Corp.

K number K965046

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MNH 1997-02-13

SYNTHES (U.S.A.) UNIVERSAL SACRAL SYSTEM

Applicant Synthes (Usa)

K number K963045

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MNH 1997-02-11

OSTEONICS SPINAL SYSTEM - VARIABLE OFFSET CONNECTOR ASSEMBLY

Applicant Osteonics Corp.

K number K964544

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MNH 1997-01-17

OSTEONICS SPINAL SYSTEM-TOPLOADING TRANSVERSE CONNECTOR ASSEMBLY

Applicant Osteonics Corp.

K number K964304

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MNH 1997-01-16

SYNERGY(TM) TI POSTERIOR SPINAL SYSTEM

Applicant Buckman Co., Inc.

K number K950099

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MNH 1997-01-09

MODIFICATION TO THE SYNTHES (USA) UNIVERSAL SPINAL HOOK, ROD, AND AND SACRAL SCREW FIXATION SYSTEM IN 316L STAINLESS STE

Applicant Synthes (Usa)

K number K963357

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MNH 1996-12-16

ACROMED CABLE/WIRE PEDICLE SCREW

Applicant Acromed Corp.

K number K964007

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MNH 1996-12-09

SYNTHES (U.S.A.) UNIVERSAL SPINAL PARALLEL CONNECTOR

Applicant Synthes (Usa)

K number K962608

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MNH 1996-10-22

ISOLA TWISTER CONNECTOR

Applicant Acromed Corp.

K number K962645

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MNH 1996-10-02

ULTIUM SPINAL PLATING SYSTEM

Applicant Smith & Nephew, Inc., Orthopaedic Div.

K number K962784

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MNH 1996-09-25

J.B.S. SPINE SYSTEM WITH PEDICLE SCREWS - ADDITIONAL COMPONENTS - SCREWS, LINKING PLATES, HOOKS AND ROD CLAMP

Applicant J.B.S., S.A.

K number K962757

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MNH 1996-09-17

VERSALOK SCREW ASSEMBLY (PROPOSED NAME)

Applicant Wrightmedicaltechnologyinc

K number K961572

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MNH 1996-05-03

DDS SPINAL SYSTEM

Applicant Encore Orthopedics, Inc.

K number K960107

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MNH 1996-04-18

WEBB-MORLEY SPINE SYSTEM

Applicant Buckman Co., Inc.

K number K960451

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MNH 1996-02-21

SPINE SYSTEM SACRAL PLATE

Applicant J.B.S., S.A.

K number K953881

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MNH 1996-02-15

MOSS MIAMI SPINAL SYSTEM (ANTERIOR USE)

Applicant Depuy, Inc.

K number K953915

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MNH 1996-02-14

AUGMENT-T POSTERIOR SPINAL SYSTEM

Applicant Sofamor Danek USA,Inc.

K number K950717

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MNH 1996-02-14

SPINE FIXATION

Applicant Danek Medical, Inc.

K number K943827

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MNH 1996-01-25

KSF POSTERIOR SPINGAL FIXATOR FOR SEVERE SPONDYLOLISTHESIS

Applicant Buckman Co., Inc.

K number K950999

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MNH 1996-01-22

ISOLA SYSTEM

Applicant Acromed Corp.

K number K952236

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MNH 1995-12-13

SPINAL PEDICLE SCREW, FIXATION, APPLIANCE

Applicant J.B.S., S.A.

K number K952298

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MNH 1995-11-21

AMSET R-F SYSTEM

Applicant Advanced Spine Technology, Inc.

K number K951266

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MNH 1995-11-07

SADDLE WITH ANCHOR, STAINLESS STEEL VARIFIX SYSTEM

Applicant Advanced Spine Fixation Systems, Inc.

K number K953779

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MNH 1995-11-06

SADDLE WITH ANCHOR, TITANIUM VARIFIX SYSTEM

Applicant Advanced Spine Fixation Systems, Inc.

K number K953778

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MNH 1995-10-30

TITANIUM DYNA-LOK SPINAL SYSTEM

Applicant Sofamor Danek USA,Inc.

K number K953635

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MNH 1995-10-03

BRYAN POSTERIOR SPINAL FIXATOR (BPSF)

Applicant Arcan Orthopaedic Corp.

K number K953416

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MNH 1995-09-08

STAINLESS STEEL VARIFIX SYSTEM 5.0MM DIAMETER ANCHOR SCREW

Applicant Advanced Spine Fixation Systems, Inc.

K number K953369

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MNH 1995-09-08

OSTEONICS SPINAL SYSTEM

Applicant Osteonics Corp.

K number K951725

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MNH 1995-09-01

ROGOZINSKI SPINAL ROD SYSTEM ROD-TO-BOLT (UNIVERSAL) CONNECTOR FOR USE WITH THE SIMMONS PLATING SYSTEM BOLT

Applicant Smith & Nephew Richards, Inc.

K number K950865

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MNH 1995-08-28

GDLH POSTERIOR SPINAL SYSTEM

Applicant Sofamor Danek USA,Inc.

K number K950596

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MNH 1995-08-25

PARAGON POSTERIOR SPINAL SYSTEM

Applicant Sofamor Danek USA,Inc.

K number K950955

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MNH 1995-08-21

SYNTHES (USA) UNIV. SCREW FIXATION SYSTEM (TITANIUM)

Applicant Synthes (Usa)

K number K951794

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MNH 1995-08-21

VSP (VARIABLE SCREW PLACEMENT) SPINAL FIXATION SYSTEM, PEDICLE SCREW(S), SPINE PLATE(S), WASHER(S) & NUT(S)

Applicant Acromed Corp.

K number K951657

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MNH 1995-08-21

SYNTHES (U.S.A.) UNIVERSAL SPINAL HOOK, ROD AND PEDICLE/SACRAL SCREW FIXATION SYSTEM

Applicant Synthes (Usa)

K number K951626

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MNH 1995-08-14

DYNA-LOK ANTERIOR PLATING SYSTEM

Applicant Danek Group, Inc.

K number K936307

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MNH 1995-08-11

ACROMED PEDICLE SCREW

Applicant Acromed Corp.

K number K951116

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MNH 1995-08-11

WRIGHT-LOC(TM) SPINAL FIXATION SYSTEM

Applicant Wrightmedicaltechnologyinc

K number K950074

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MNH 1995-08-07

TITANIUM TSRH(R) SPINAL SYSTEM (SCREWS)

Applicant Sofamor Danek USA,Inc.

K number K946348

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MNH 1995-07-26

5.8MM DIAMETER ANCHOR SCREW

Applicant Advanced Spine Fixation Systems, Inc.

K number K951308

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MNH 1995-07-25

TITANIUM LOW PROFILE CROSS BAR

Applicant Advanced Spine Fixation Systems, Inc.

K number K951172

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MNH 1995-07-21

DEPUY MOTECH MOSS SPINAL SYSTEM - PEDICLE FIXATION

Applicant Depuy Motech

K number K950695

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MNH 1995-07-13

CROSS MEDICAL - SYNERGY(TM) SPINE SYSTEM

Applicant Cross Medical Products, Inc.

K number K940631

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MNH 1995-06-22

DEPUY MOTECH MOSS MIAMI SPINAL SYSTEM - PEDICLE FIXATION

Applicant Depuy Motech

K number K950697

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MNH 1995-06-22

ISOLA SPINE SYSTEM

Applicant Acromed Corp.

K number K944737

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MNH 1995-06-20

SIMMONS PLATING SYSTEM BOLT AND SCREW

Applicant Smith & Nephew, Inc.

K number K930353

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MNH 1995-06-14

ROGOZINSKI SPINAL ROD SYSTEM SCREW

Applicant Smith & Nephew Richards, Inc.

K number K930298

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MNH 1995-05-30

ISOLA OPEN AND CLOSED SCREWS

Applicant Acromed Corp.

K number K944756

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MNH 1995-05-05

VSP (VARIABLE SCREW PLACEMENT)

Applicant Acromed Corp.

K number K944736

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MNH 1995-04-26

SELBY INSTRUMENTATION

Applicant Advanced Spine Fixation Systems, Inc.

K number K945064

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MNH 1995-04-26

SELBY INSTRUMENTATION

Applicant Advanced Spine Fixation Systems, Inc.

K number K943775

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MNH 1995-02-14

SELBY INSTRUMENTATION

Applicant Advanced Spine Fixation Systems, Inc.

K number K942387

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MNH 1995-01-20

TSRH SPINAL SCREWS

Applicant Sofamor Danek Mfg., Inc.

K number K932029

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