ClearanceBrief
Panels › Orthopedic › Product code MEH · Class 2

Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate

Regulation 888.3353

1510(k)s in 12 months (160 all time)
1recalls in 12 months (197 all time)
190recalls that name a 510(k)
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Top companies in MEH

Decided510(k)Device and applicantCode
Nov 23, 2010K093472TRINITY ACETABULAR SYSTEM
Corin USA
MEH
Jul 15, 2010K100481SMITH & NEPHEW MDF MODULAR SLEEVE
Smith & Nephew, Inc.
MEH
Apr 21, 2010K090982SMITH & NEPHEW HIP SYSTEMS WITH HA
Smith & Nephew, Inc.
MEH
Mar 12, 2010K092265VESAFITCUP DOUBLE MOBILITY- HIGHCROSS HXUHMWPE LINERS
Medacta International S.A.
MEH
Dec 18, 2009K093644RESTORATION ADM SYSTEM X3 ACETABULAR
Howmedica Osteonics Corp.
MEH
Nov 4, 2009K092406ABG II MODULAR HIP STEM
Howmedica Osteonics Corp.
MEH
Oct 20, 2009K092561REJUVENATE MODULAR STEM
Howmedica Osteonics Corp.
MEH
Sep 22, 2009K092143EXCIA TOTAL HIP SYSTEM M AN ML FEMORAL STEM
Aesculap Implant Systems, Inc.
MEH
Jun 16, 2009K091161REJUVENATE MONOLITHIC SIZE 4 HIP STEM
Howmedica Osteonics Corp.
MEH
Apr 7, 2009K083116VERSAFIT CUP DOUBLE MOBILITY SYSTEM
Medacta International S.A.
MEH
Dec 29, 2008K082892REJUVENATE MONOLITHIC HIP SYSTEM
Howmedica Osteonics Corp.
MEH
Jul 31, 2008K081124MDF REVISION HIP SYSTEM
Smith & Nephew, Inc.
MEH
Jun 3, 2008K081044REJUVENATE MODULAR HIP SYSTEM
Howmedica Osteonics Corp.
MEH
Jun 2, 2008K071916METHA HIP SYSTEM
Aesculap Implant Systems, Inc.
MEH
May 9, 2008K080584METHA SHORT STEM HIP SYSTEM
Aesculap Implant System, Inc.
MEH
May 6, 2008K080980EXACTECH NOVATION ELEMENT PRESS-FIT FEMORAL STEMS
Exactech, Inc.
MEH
Oct 18, 2007K072020RESTORATION ADM SYSTEM
Howmedica Osteonics Corp.
MEH
Jul 25, 2007K071583CERMET III ACETABULAR CUP SYSTEM
Implants International, Ltd., GB
MEH
Mar 22, 2006K060437EXCIA TOTAL HIP SYSTEM WITH U-CAP
Aesculap, Inc.
MEH
Jan 13, 2006K053528SHORT CITATION FEMORAL STEM
Stryker Orthopaedics
MEH
Dec 7, 2005K052426SMITH & NEPHEW MODULAR HIP
Smith & Nephew, Inc.
MEH
Dec 8, 2004K043079BICONTACT HIP SYSTEM WITH U-CAP
Aesculap
MEH
Nov 19, 2004K042127SMITH & NEPHEW MODULAR HIP
Smith & Nephew, Inc.
MEH
Oct 8, 2004K041353FURLONG H-AC TOTAL HIP REPLACEMENT SYSTEM
Jri Manufacturing, Ltd.
MEH
Jun 14, 2004K040680CONTOUR HA COATED RECONSTRUCTION RING
Smith & Nephew, Inc.
MEH
Jun 4, 2004K040613EXACTECH ACUMATCH A-SERIES AND MCS ACETABULAR SHELLS AND LINERS
Exactech, Inc.
MEH
Jan 20, 2004K032641MODIFICATION TO: THE MARGRON HIP REPLACEMENT SYSTEM
Portland Orthopaedics Pty. , Ltd., AU
MEH
Oct 9, 2003K032300ACCOLADE-J HIP STEM SERIES
Howmedica Osteonics Corp.
MEH
Oct 25, 2002K023302ECHELON POROUS PLUS HA HIP STEMS
Smith & Nephew, Inc.
MEH
Oct 9, 2002K023102ACCOLADE TMZF PLUS HA 127 SIZE 0 HIP STEM
Howmedica Osteonics Corp.
MEH
May 31, 2002K021403HA MALLORY/HEAD POROUS FEMORAL STEM & HA MALLORY/HEAD POROUS LATERALIZED FEMORAL STEM
Biomet Orthopedics, Inc.
MEH
May 13, 2002K020615SUPER SECUR-FIT HA HIP STEMS AND SUPER SECUR-FIT PLUS HA HIP STEMS
Howmedica Osteonics Corp.
MEH
May 3, 2002K021108ESOP HA FEMORAL STEM
Fournitures Hospitalieres
MEH
Apr 16, 2002K020963TAPERLOC POROUS FEMORAL STEM & HA TAPERLOC POROUS LATERALIZED FEMORAL STEM
Biomet Orthopedics, Inc.
MEH
Mar 4, 2002K020572ACCOLADE TMZF HA 132 DEGREE SIZE 0 HIP STEM
Howmedica Osteonics Corp.
MEH
Dec 5, 2001K013676TRIDENT HEMISPHERICAL ACETABULAR SHELLS
Howmedica Osteonics Corp.
MEH
Dec 11, 2000K002996SYNERGY HA COATED POROUS FEMORAL STEMS
Smith & Nephew, Inc.
MEH
Aug 17, 2000K001580GROSS FEMORAL COMPONENT
Biomet, Inc.
MEH
Aug 4, 2000K001448TRIDENT ACETABULAR SHELLS: PS-HA
Howmedica Osteonics Corp.
MEH
Apr 3, 2000K000262BOHN FEMORAL COMPONENT
Biomet Manufacturing, Inc.
MEH
Mar 16, 2000K994366TMZF PRESS FIT HA STEM AND TMZF PRESS FIT PLUS HA STEM
Howmedica Osteonics Corp.
MEH
Feb 16, 2000K000242ACUMATCH A-SERIES CORUNDUM ACETABULAR COMPONENT AND ACUMATCH A-SERIES CORUNDUM ACETABULAR COMPONENT WITH HYDROXYAPATITE
Exactech, Inc.
MEH
Feb 7, 2000K992815THE MARGRON HIP REPLACEMENT SYSTEM
Portland Orthopaedics Pty. , Ltd., AU
MEH
Feb 4, 2000K993943ENCORE LINEAR POROUS COATED HIP WITH HA, ENCORE FOUNDATION POROUS HIP WITH HA, ENCORE REVELATION POROUS HIP WITH HA
Encore Orthopedics, Inc.
MEH
Jan 21, 2000K993768CITATION TMZF HA STEM
Howmedica Osteonics Corp.
MEH
Oct 8, 1999K993077HOWMEDICA OSTEONICS RESTORATION HA HIP STEM
Howmedica Osteonics Corp.
MEH
Aug 13, 1999K992025PRECISION OSTEOLOCK FEMORAL STEMS WITH PURE-FIX HA COATING
Howmedica Osteonics Corp.
MEH
Aug 6, 1999K990666HYDROXYAPATITE (HA) REFLECTION ACETABULAR SHELL, HYDROXYAPATITE (HA) REFLECTION INTERFIT SHELL
Smith & Nephew, Inc.
MEH
Jul 23, 1999K980070OSTEONICS HA-COATED DEVICES
Osteonics Corp.
MEH
Feb 18, 1999K990203OSTEONICS PRIMARY SECUR-FIT PLUS HIP STEMS
Osteonics Corp.
MEH

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