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

Company510(k)sRecalls
Stryker Howmedica Osteonics088
Portland Orthopaedics Pty. , Ltd.271
Osteonics Corp.240
Howmedica Osteonics Corp.193
Corin U.S.A. Limited614
Smith & Nephew, Inc.135
Exactech, Inc.83
Signature Orthopaedics Pty, Ltd.80
Biomet, Inc.31
Depuy, Inc.40
Decided510(k)Device and applicantCode
Oct 4, 1991K912452HA MCCUTCHEN SLT HIP SYSTEM
Dow Corning Wright
MEH
Aug 29, 1991K912263HA ANATOMIC HIP PROSTH W/ TI-NIDIUM SURF HARD PROC
Zimmer, Inc.
MEH
Aug 16, 1991K912654OMNIFIT EPF DUAL GEOMETRY ACETABULAR CUP
Osteonics Corp.
MEH
Aug 16, 1991K911728OMNIFIT(R) EPF DUAL GEOMTRY/RADIUS/THREAD ACETAB C
Osteonics Corp.
MEH
Jul 24, 1991K912395HOWMEDICA PRECIS OSTEOLOCK FEM COMP W/HYDRO COAT
Howmedica Corp.
MEH
Jul 1, 1991K911585OMNIFIT II EPF HIP STEM SERIES
Osteonics Corp.
MEH
Jun 7, 1991K910156HYDROXYAPATITE COATED PROFILE(R) HIP STEM
Depuy, Inc.
MEH
Mar 26, 1991K910755PREMIER-TOTAL(TM) HIP WITH CALCITITE(R) COATING
Intermedics Orthopedics
MEH
Mar 4, 1991K905781APR AND APR II PRESS-FIT UNIVERSAL HIP SYSTEM
Intermedics Orthopedics
MEH
Dec 20, 1990K896047THE OMNIFIT EPF HIP JOINT FEMORAL STEM
Osteonics Corp.
MEH

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