Prosthesis, Hip, Cement Restrictor

FDA product code JDK · 54 cleared devices

Class 2 General, Plastic Surgery

Regulation: 21 CFR 878.3300
Review panel: OR
Implant: Yes
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1983-07-12 – 2021-04-08

JDK 2021-04-08

Mectaplug PE II

Applicant Medacta International S.A.

K number K210062

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JDK 2006-10-05

KMI CEMENT RESTRICTOR IMPLANT

Applicant Kinetikos Medical, Inc.

K number K061465

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JDK 2006-07-12

MODIFICATION TO LIFE SPINE CEMENT RESTRICTOR

Applicant Life Spine

K number K061698

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JDK 2006-05-11

LIFE SPINE CEMENT RESTRICTOR

Applicant Life Spine

K number K060247

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JDK 2006-03-16

SPINAL USA CEMENT RESTRICTOR SYSTEM

Applicant Spinal USA

K number K060132

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JDK 2005-12-06

INTERBODY INNOVATIONS CEMENT RESTRICTOR

Applicant Interbody Innovations, Llp

K number K051371

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JDK 2005-11-21

SKELITE RESORBABLE CEMENT RESTRICTOR

Applicant Millenium Biologix, Inc.

K number K051836

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JDK 2005-10-07

NOVASPINE CEMENT RESTRICTOR NSCR

Applicant Novaspine, LLC

K number K051607

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JDK 2005-10-05

SCIENT'X CEMENT RESTRICTOR

Applicant Scient'X

K number K052367

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JDK 2005-06-17

POLYGRAFT BGS; BONE GRAFT SUBSTITUTE

Applicant Osteobiologics, Inc.

K number K041382

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JDK 2005-04-15

MODIFICATION TO: VENTED CEMENT RESTRICTOR, MODEL 60102-000-001/004

Applicant Amedica Corp.

K number K050699

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JDK 2004-07-22

PEEK CEMENT RESTRICTOR X-BOX

Applicant Innovasis, Inc.

K number K041583

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JDK 2004-07-06

OPTIMESH 500E CEMENT RESTRICTOR

Applicant Spineology, Inc.

K number K033953

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JDK 2004-04-30

QUANTUM CEMENT RESTRICTOR

Applicant Quantum Orthopedics

K number K040276

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JDK 2003-12-22

FIDJI LARGE CEMENT RESTRICTOR

Applicant Spine Next SA

K number K030871

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JDK 2003-12-22

FIDJI SMALL CEMENT RESTRICTOR

Applicant Spine Next SA

K number K030767

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JDK 2003-11-19

THE HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEM, MODEL 06-165-ZZZZ

Applicant Implex Corp.

K number K033384

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JDK 2003-10-07

NUVASIVE CEMENT RESTRICTOR

Applicant Nuvasive, Inc.

K number K032180

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JDK 2003-08-22

TRAXIS CEMENT RESTRICTOR

Applicant Spinal Concepts, Inc.

K number K031318

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JDK 2003-08-08

INTERPORE CROSS CEMENT RESTRICTOR

Applicant Interpore Cross Intl.

K number K032095

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JDK 2003-07-24

MODIFICATION TO FORTITUDE CEMENT RESTRICTOR

Applicant Spinal Concepts, Inc.

K number K031837

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JDK 2003-06-12

OTI BONE CEMENT PLUG

Applicant Osteoimplant Technology, Inc.

K number K030608

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JDK 2003-05-16

INTERPORE CROSS CEMENT RESTRICTOR

Applicant Interpore Cross Intl.

K number K023908

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JDK 2002-11-27

CADENCE PEEK CEMEENT RESTRICTOR

Applicant Spinal Concepts, Inc.

K number K023647

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JDK 2002-10-29

CENTERPULSE, SPINE-TECH DIVISION CEMENT RESTRICTOR

Applicant Centerpulse Spine-Tech, Inc.

K number K022615

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JDK 2002-10-04

NBD CEMENT RESTRICTOR DEVICE

Applicant New Business Development, LLC

K number K021788

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JDK 2002-08-16

CEMENT RESTRICTOR, SMALL AND LARGE

Applicant Exactech, Inc.

K number K021765

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JDK 2002-08-15

FORTITUDE CEMENT RESTRICTOR

Applicant Spinal Concepts, Inc.

K number K021719

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JDK 2002-08-12

CADENCE CEMENT RESTRICTOR

Applicant Spinal Concepts, Inc.

K number K022218

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JDK 2002-06-11

RABEA CEMENT RESTRICTOR

Applicant Signus Medical, LLC

K number K020836

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JDK 2002-05-02

RPX TITANIUM CEMNT RESTRICTOR

Applicant Sulzer Spine-Tech

K number K020344

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JDK 2001-12-05

CEMENT RESTRICTOR

Applicant Medtronic Sofamor Danek, Inc.

K number K013663

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JDK 2001-10-29

THEKEN LARGE CEMENT RESTRICTOR

Applicant Theken Surgical,Llc

K number K012462

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JDK 2001-10-17

THEKEN SMALL CEMENT RESTRICTOR

Applicant Theken Surgical,Llc

K number K012278

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JDK 2001-10-10

TITANIUM CEMENT RESTRICTOR MATERIAL PEEK

Applicant Medtronic Sofamor Danek USA, Inc.

K number K010528

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JDK 2001-10-04

BLOCK CEMENT RESTRICTOR (CR) - TITANIUM

Applicant Medtronic Sofamor Danek, Inc.

K number K013014

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JDK 2001-08-03

THREADED CEMENT RESTRICTOR (CR) TITANIUM

Applicant Medtronic Sofamor Danek USA, Inc.

K number K011443

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JDK 2001-08-01

MEDTRONIC SOFAMOR DANEK CEMENT RESTRICTOR

Applicant Medtronic Sofamor Danek, Inc.

K number K012255

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JDK 2001-07-26

METRONIC SOFAMOR DANEK CEMENT RESTRICTOR

Applicant Medtronic Sofamor Danek, Inc.

K number K011998

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JDK 2001-02-14

TITANIUM CEMENT RESTRICTOR (TCR)

Applicant Medtronic Sofamor Danek, Inc.

K number K003718

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JDK 1999-07-30

RABEA DEVICE, MODEL PXXXXXX

Applicant Signus Medizintechnik GmbH

K number K990345

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JDK 1997-02-28

OSTEONICS SCREW HOLE PLUGS

Applicant Osteonics Corp.

K number K965056

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JDK 1994-03-22

BONE CEMENT RESTRICTOR

Applicant Biodynamic Technologies, Inc.

K number K926216

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JDK 1992-10-30

OMNIFLEX-C UHMWPE MID-SHAFT RESTRICTOR

Applicant Osteonics Corp.

K number K923616

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JDK 1991-06-28

LIMA CEMENT RESTRICTOR

Applicant Turnkey Intergration USA, Inc.

K number K911338

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JDK 1991-04-08

OSTEONICS(R) MID-SHAFT CEMENT SPACER

Applicant Osteonics Corp.

K number K910461

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JDK 1990-11-20

S-ROM(TM) FEMORAL STEM CENTRALIZER/CEMENT SPACER

Applicant Joint Medical Products Corp.

K number K904746

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JDK 1990-03-06

OSTEONICS CEMENT RESTRICTOR

Applicant Osteonics Corp.

K number K900462

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JDK 1989-11-22

PROXIMAL CEMENT SPACER

Applicant Osteonics Reconstructive Products Div.

K number K895378

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JDK 1989-10-10

PT DISTAL TIP CEMENT SPACER

Applicant Osteonics Corp.

K number K894708

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JDK 1987-12-29

OMNIFIT DISTAL STEM CEMENT SPACERS

Applicant Osteonics Corp.

K number K872528

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JDK 1984-03-05

CEMENT RESTRICTOR

Applicant American Ortomed Corp.

K number K840413

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JDK 1983-09-29

DOSIMETRY RELEASE OF RADIATION STERILIZ

Applicant Biomet, Inc.

K number K831512

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JDK 1983-07-12

BARD INTRAMEDULLARY PLUG

Applicant C.R. Bard, Inc.

K number K831128

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