Rod, Fixation, Intramedullary And Accessories

FDA product code HSB · 490 cleared devices

Class 2 Orthopedic

Regulation: 21 CFR 888.3020
Review panel: OR
Implant: Yes
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1977-11-11 – 2026-09-24

HSB 1997-02-28

INTRAMEDULLARY NAIL SYSTEM

Applicant Zimmer, Inc.

K number K965098

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HSB 1996-12-27

TRIMAX NAIL SYSTEM

Applicant Smith & Nephew Richards, Inc.

K number K964163

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HSB 1996-12-05

HUMERUS WIRES

Applicant Compagnie Financiere & Medicale (Cf&M)

K number K964243

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HSB 1996-10-28

TBD

Applicant Acu Med, Inc.

K number K963026

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HSB 1996-10-01

TBD

Applicant Acu Med, Inc.

K number K963077

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HSB 1996-09-25

SUPRACONDYLAR INTRAMEDULLARY NAIL

Applicant Zimmer, Inc.

K number K962561

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HSB 1996-09-25

EZ-6 PROXIMAL HUMERAL INTERAMEDULLARY ROD SYSTEM

Applicant Biodynamic Technologies, Inc.

K number K962552

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HSB 1996-08-28

EZ-FIX MIDSHAFT HUMERAL INTRAMEDULLARY ROD SYSTEM

Applicant Biodynamic Technologies, Inc.

K number K962553

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HSB 1996-07-24

POLARUS AF ROD

Applicant Acu Med, Inc.

K number K962091

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HSB 1996-05-08

ORTHOFIX TIBIAL NAILING SYSTEM

Applicant Orthofix, Inc.

K number K961027

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HSB 1996-03-22

ALTA CFX IM ROD SYSTEM

Applicant Howmedica Corp.

K number K960524

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HSB 1996-03-13

TIBIA ORTHONAIL

Applicant Orthologic Corp.

K number K955761

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HSB 1996-03-08

TI-6AL-7NB URTN

Applicant Synthes (Usa)

K number K932330

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HSB 1996-01-25

FIXANO I.F.O (INTERLOCKING FLEXIBLE OSTEOSYNTHESIS) SYSTEM

Applicant Ferguson Medical

K number K954756

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HSB 1995-12-13

ALTA TIBIAL/HUMERAL ROD

Applicant Howmedica Corp.

K number K954554

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HSB 1995-10-31

SYNTHES FLEXNAIL

Applicant Synthes (Usa)

K number K953334

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HSB 1995-09-29

INTRAMEDULLARY COMPRESSION ARTHRODESIS (ICA) NAIL

Applicant Howmedica Corp.

K number K952923

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HSB 1995-09-15

ORTHONAIL

Applicant Orthologic Corp.

K number K952739

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HSB 1995-08-11

INTRAMEDULARY FIXATION ROD

Applicant Acu Med, Inc.

K number K951740

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HSB 1995-07-13

TENTATIVELY POLARUS EX ROD

Applicant Acu-Med, Inc.

K number K952534

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HSB 1995-07-06

ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Applicant Acu Med, Inc.

K number K951673

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HSB 1995-05-19

TIBIA-TALUS-CALCANEUS NAIL

Applicant Smith & Nephew Richards, Inc.

K number K950394

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HSB 1995-03-21

FEMROD AND FEMROD RECON INSERT

Applicant Applied Osteo Systems, Inc.

K number K935383

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HSB 1995-01-27

TRUE/FLEXTM FEMUR RODS, CAPS, SCREWS AND INSTRUMENTATION

Applicant Applied Osteo Systems, Inc.

K number K933995

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HSB 1994-11-28

TRUE/FLEX INTRAMEDULLARY ROD END-CAP

Applicant Applied Osteo Systems, Inc.

K number K944501

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HSB 1994-10-11

ALTA FEMORAL INTRAMEDULLARY RODS/CFX RODS MODIFICATION

Applicant Howmedica Corp.

K number K935295

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HSB 1994-06-30

OSTEO INTERLOCKING-COMPRESSION NAIL

Applicant Osteo AG

K number K933340

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HSB 1994-03-29

INTRAMEDULLARY SYSTEMS

Applicant Baumer Ortopedia , Ltd.

K number K930972

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HSB 1994-03-22

AIM SUPRACONDYLAR NAIL

Applicant Ace Orthopedic Manufacturing Co.

K number K934962

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HSB 1994-03-22

ACE HUMERAL NAIL

Applicant Ace Orthopedic Manufacturing Co.

K number K934643

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HSB 1994-03-14

SYNTHES UNREAMED HUMERAL NAIL (URHN)

Applicant Synthes (Usa)

K number K933518

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HSB 1994-03-10

ACCESS TO SYNTHES TI-6A1-7NB UNREAMED FEMORAL NAIL

Applicant Synthes (Usa)

K number K932593

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HSB 1994-02-22

TRUE/FLEX CLAVICLE RODS

Applicant Applied Osteo Systems, Inc.

K number K934148

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HSB 1994-02-22

ACUMED RADIUS ROD

Applicant Acu Med, Inc.

K number K933361

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HSB 1994-02-22

THE MODULAR NAIL

Applicant Smith & Nephew Richards, Inc.

K number K933027

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HSB 1993-07-02

SEIDEL HUMERAL LOCKING NAIL

Applicant Howmedica Corp.

K number K931256

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HSB 1993-06-17

ALTA CFX ROD SYSTEM

Applicant Howmedica Corp.

K number K926232

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HSB 1993-06-17

MODIFIED ZICKEL INTRAMEDULLARY ROD SYSTEM

Applicant Osteo Technology, Inc.

K number K926213

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HSB 1993-03-04

SEIDEL HUMERAL LOCKING NAIL & ADDITIONAL LENGTHS

Applicant Howmedica Corp.

K number K925544

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HSB 1993-01-21

SYNTHES TITANIUM UNREAMED FEMORAL NAIL

Applicant Synthes (Usa)

K number K923597

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HSB 1993-01-21

SYNTHES TI-6AI-7NB UNREAMED FEMORAL NAIL

Applicant Synthes (Usa)

K number K923580

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HSB 1992-11-24

TRUE/ FLEX FIBULA RODS

Applicant Applied Osteo Systems, Inc.

K number K924656

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HSB 1992-09-21

ALTA FEMORAL INTRAMEDULLARY ROD SYSTEM, ADD SIZES

Applicant Howmedica Corp.

K number K922266

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HSB 1992-08-05

INTRAMEDULARY FIXATION ROD

Applicant Acu Med, Inc.

K number K920666

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HSB 1992-07-23

OSTEO TIBIA NAIL

Applicant Osteo AG

K number K922196

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HSB 1992-07-23

OSTEO FEMORAL NAIL

Applicant Osteo AG

K number K922195

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HSB 1992-04-28

TRUE/FLEX HUMERUS CAP

Applicant Applied Osteo Systems, Inc.

K number K920598

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HSB 1992-03-02

INTERLOCKING TIBIAL NAILING SYSTEM

Applicant Stryker Corp.

K number K915435

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HSB 1992-01-17

TRUE/FLEX HUMERUS, ULNA & RADIUS INTRAMED RODS SYS

Applicant Applied Osteo Systems, Inc.

K number K913949

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HSB 1992-01-13

INTERLOCKING FEMORAL NAILING SYSTEM

Applicant Stryker Corp.

K number K912930

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HSB 1991-10-15

TRUE/FLEX TIBIAL RODS WITH CAP

Applicant Applied Osteo Systems, Inc.

K number K912710

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HSB 1991-09-23

ORTHOFIX UNREAMED TIBIAL NAIL SYSTEM

Applicant Scientific Research

K number K912420

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HSB 1991-07-08

AIM TIBIAL NAIL

Applicant Ace Medical Co.

K number K911554

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HSB 1991-03-05

ALTA(R) PFX IM ROD

Applicant Howmedica Corp.

K number K903526

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HSB 1990-07-30

HANSEN-STREET TYPE INTRAMEDULLARY NAIL

Applicant Onyx Medical Corp.

K number K903256

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HSB 1990-07-12

TRUE/FLEX HUMERUS, ULNA AND RADIUS INTRAMEDULLARY

Applicant Applied Osteo Systems, Inc.

K number K902264

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HSB 1989-11-16

RUSSELL-TAYLOR INTRAMEDULLARY KNEE FUSION NAILS

Applicant Richards Medical Co., Inc.

K number K893377

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HSB 1989-06-05

ALTA HOLLOW TIBIAL RODS

Applicant Howmedica Corp.

K number K890936

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HSB 1989-01-18

ALTA NON-REAMED TIBIAL ROD

Applicant Howmedica Corp.

K number K884500

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HSB 1988-12-01

INTERLOCKING INTRAMEDULLARY NAILS

Applicant Depuy, Inc.

K number K884610

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HSB 1988-11-28

TRACER SKELETAL TRACTION PINS

Applicant De Medica Mfg., Inc.

K number K884407

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HSB 1988-06-30

ZINDRICK IM ROD INSTRUMENTS

Applicant Buckman Co., Inc.

K number K882443

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HSB 1988-03-14

SELF GUIDING (SG) INTERLOCKING NAIL

Applicant Orthopaedic Designs, Inc.

K number K880737

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HSB 1987-08-17

ZINDRICK IM ROD

Applicant Buckman Co., Inc.

K number K871539

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HSB 1987-08-05

MODIFIED HUCKSTEP INTRAMEDULLARY NAIL

Applicant Downs Surgical , Ltd.

K number K871947

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HSB 1987-06-30

SARMIENTO FOREARM NAIL

Applicant Depuy, Inc.

K number K871814

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HSB 1987-06-23

HI MARC INTERLOCKING NAIL

Applicant Depuy, Inc.

K number K871872

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HSB 1987-05-08

RODRIGUEZ NAIL

Applicant Richards Medical Co., Inc.

K number K871608

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HSB 1987-03-26

INTRAMEDULLARY NAIL

Applicant The Deca Co.

K number K870040

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HSB 1986-05-06

FASICULATED NAIL

Applicant Lake Region Mfg., Inc.

K number K861365

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HSB 1986-03-28

GROSSE AND KEMPF LOCKING NAIL SYSTEM, NON-SLOT ROD

Applicant Howmedica Corp.

K number K860756

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HSB 1986-03-19

ACE IM ROD

Applicant Buckman Co., Inc.

K number K860592

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HSB 1986-02-12

FEMOROTIBIAL MEDULLARY NAIL

Applicant Zimmer, Inc.

K number K853250

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HSB 1986-02-04

FASCILULATED NAIL

Applicant The Deca Co.

K number K854227

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HSB 1985-12-09

KIRSCHNER INTRAMEDULLARY NAIL SYSTEM

Applicant Kirschner Medical Corp.

K number K854338

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HSB 1985-05-22

INTERLOCKING FEMORAL NAIL(LEFT & RIGHT) TIBIAL NAI

Applicant Warsaw Orthopedic, Inc.

K number K852020

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HSB 1985-04-19

MEC INTRAMEDULLARY ROD

Applicant Pfizer, Inc.

K number K850441

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HSB 1985-02-07

ACE INTRAMEDULLARY ROD FOR SMALL BONES

Applicant Buckman Co., Inc.

K number K850142

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HSB 1983-03-01

INTRAMEDULLARY ROD

Applicant The Deca Co.

K number K830087

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HSB 1982-04-15

MECRON CONCAVEX FLEXIBLE INTRAMEDULLARY

Applicant Serrano Intl.

K number K820852

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HSB 1982-03-01

GROSSE AND KEMPF LOCKING NAIL SYS.

Applicant Howmedica Corp.

K number K813371

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HSB 1981-04-29

ENDER PINS

Applicant Richard'S Medical Equip., Inc.

K number K811002

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HSB 1981-04-17

MARCOVE INTRAMEDULLARY ROD

Applicant Hexcel Medical

K number K810957

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HSB 1981-04-17

MARCOVE HUMERAL ROD

Applicant Hexcel Medical

K number K810956

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HSB 1981-03-13

MOURADIAN MODIFIED ZICKEL HUMERAL ROD

Applicant Howmedica Corp.

K number K810535

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HSB 1981-02-12

AGINSKY NAIL

Applicant Cintor Orthopaedic Div.

K number K803106

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HSB 1981-02-09

FLEXIBLE PIN S SHAPED INTRAMED. SYSTEM

Applicant Howmedica Corp.

K number K803196

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HSB 1980-05-20

KIRSCHNER WIRE

Applicant American Safety Equipment Corp.

K number K801010

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HSB 1979-12-05

CURVED KUNTSCHER INTRAMEDULLARY NAIL

Applicant Howmedica Corp.

K number K792203

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HSB 1977-11-11

NAIL, INTRAMEDULLARY, FLEXIBLE

Applicant Depuy, Inc.

K number K772081

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