ClearanceBrief
Panels › Orthopedic › Product code KXA · Class 2

Prosthesis, Hip, Femoral, Resurfacing

Regulation 888.3400

0510(k)s in 12 months (23 all time)
0recalls in 12 months (16 all time)
16recalls that name a 510(k)
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Top companies in KXA

Company510(k)sRecalls
DePuy Orthopaedics, Inc.113
Zimmer GmbH13
Biomet, Inc.20
Biomet Orthopedics, Inc.20
Biopro, Inc.20
Corin USA20
Orthomet, Inc.20
Waldemar Link GmbH & Co. KG20
Wrightmedicaltechnologyinc20
Biocore9, LLC10
Decided510(k)Device and applicantCode
Jan 19, 2021K201219Biocore9 Femoral Head Resurfacing Component
Biocore9, LLC
KXA
Apr 15, 2010K092198CORMET CEMENTLESS RESURFACING FEMORAL HEAD
Corin USA
KXA
Dec 12, 2008K082673CONSERVE PRESSFIT FEMORAL COMPONENT
Wrightmedicaltechnologyinc
KXA
Jun 29, 2007K071053RECAP HA PRESS-FIT FEMORAL RESURFACING HEAD
Biomet, Inc.
KXA
Apr 26, 2007K070292DUROM HIP RESURFACING SYSTEM, FEMORAL COMPONENTS
Zimmer GmbH
KXA
Dec 1, 2006K062960CONSERVE FEMORAL RESURFACING COMPONENT
Wrightmedicaltechnologyinc
KXA
May 18, 2005K043542BIOPRO TARA FEMORAL RESURFACING COMPONENT
Biopro, Inc.
KXA
Dec 4, 2003K032659DEPUY ASR RESURFACING FEMORAL HEADS
DePuy Orthopaedics, Inc.
KXA
Dec 11, 2002K023188PRESS-FIT HEAD RESURFACING DEVICE
Biomet Orthopedics, Inc.
KXA
Aug 1, 2002K021549CONTOURED ARTICULAR PROSTHESIS (CAP) FEMORAL HEAD RESURFACING SYSTEM
Std Mfg., Inc.
KXA
Jun 26, 2002K021799CEMENTED FEMORAL HEAD RESURFING DEVICE
Biomet Orthopedics, Inc.
KXA
Feb 25, 2000K994153CORMET 2000 HEMI HIP METALLIC RESURFACING PROSTHESIS
Corin USA
KXA
Dec 3, 1998K983452NELSON RESURFACING HEAD
Biomet, Inc.
KXA
Apr 13, 1995K950998MODUILAR UNIPOLAR
Intermedics Orthopedics
KXA
Dec 28, 1994K944752ORTHOMET RESURFACING FEMORAL COMPONENT
Orthomet, Inc.
KXA
May 23, 1991K904870MODIFIED NEW JERSEY FEMORAL HIP RESURFACING COMPON
Endotec, Inc.
KXA
Nov 17, 1989K894604BIOPRO PROXIMAL FEMORAL ARTICULAR REPLACEMENT
Biopro, Inc.
KXA
May 23, 1989K892398BIPOLAR HIP SYSTEM
Orthomet, Inc.
KXA
Nov 22, 1988K883212LSF (R) TOTAL HIP SYSTEM - BIPOLAR COMPONENT
Implant Technology, Inc.
KXA
Jul 20, 1984K842233NEW JERSEY FEMORAL RESURFACING COMPONENT
Endomedics, Inc.
KXA
Dec 5, 1979K792200TILLMAN HIP RESURFACING REPLACEMT PROS.
Waldemar Link GmbH & Co. KG
KXA
Sep 20, 1978K781490TILLMAN HIPSURFACE REPLACEMENT
Waldemar Link GmbH & Co. KG
KXA
Jan 5, 1977K761324RESURFACE PROSTHESES FOR HIP JOINT
Holco Instrument Corp.
KXA

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