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)
Top companies in MEH
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 4, 1999 | K990197 | MODULUS COMPATIBLE STABILITY (MCS)-HA TOTAL HIP SYSTEM Exactech, Inc. | MEH |
| Dec 11, 1998 | K983382 | OSTEONICS HA GENERATION II ACETABULAR COMPONENT SYSTEM Osteonics Corp. | MEH |
| Dec 2, 1998 | K983870 | OSTEONICS RESTORATION HA HIP STEMS Osteonics Corp. | MEH |
| Jul 9, 1998 | K982032 | OSTEONICS OMNIFIT HA HIP STEM SERIES, OSTEONICS SECUR-FIT HA HIP STEM SERIES, OSTEONICS PRIMARY SECUR-FIT PLUS HIP STEMS Osteonics Corp. | MEH |
| May 27, 1998 | K980766 | OSTEONICS ANTEVERTED NECK HA HIP STEMS Osteonics Corp. | MEH |
| Mar 5, 1998 | K964878 | ESOP S/C FEMORAL STEM Fournitures Hospitalieres | MEH |
| Oct 1, 1997 | K971523 | DISTALLY FIXED HIP STEM Sulzer Orthopedics, Inc. | MEH |
| Jul 8, 1997 | K961732 | KAR Landos, Inc. | MEH |
| May 22, 1997 | K971422 | OSTEONICS ACETABULAR WEDGE SYSTEM Osteonics Corp. | MEH |
| Apr 22, 1997 | K970394 | OSTEONICS NORMALIZED AD-HA ACETABULAR COMPONENT SYSTEM Osteonics Corp. | MEH |
| Apr 3, 1997 | K961388 | ATLAS III ACETABULAR CUP Fournitures Hospitalieres | MEH |
| Feb 28, 1997 | K970337 | HA GLOBAL TAPER (GT) TAPERED HIP STEM Smith & Nephew, Inc., Orthopaedic Div. | MEH |
| Dec 19, 1996 | K963959 | OSTEONICS MODULAR ACETABULAR CUP (HA-COATED VERSION) Osteonics Corp. | MEH |
| Apr 25, 1996 | K954800 | APR HIP SYS W/CAL-COATED CAN STR TITANIUM (CSTI) Intermedics Orthopedics | MEH |
| Jan 18, 1996 | K955305 | PCA +15MM MODULAR FEMORAL HEAD Howmedica Corp. | MEH |
| Jan 17, 1996 | K951517 | OSTEONICS SECUR-FIT HA PLUS HIP STEM SERIES Osteonics Corp. | MEH |
| Nov 22, 1995 | K954023 | OSTEONICS SECUR-FIT HA PSL EXTRA ACETABULAR COMPONENT SYSTEM Osteonics Corp. | MEH |
| Sep 6, 1995 | K951671 | OSTEONICS RESTORATION MONOLITHIC II SLOTTED HIP STEM SERIES Osteonics Corp. | MEH |
| Sep 1, 1995 | K951932 | OSTEONICS RESTORATION MONOLITHIC II HIP STEM SERIES Osteonics Corp. | MEH |
| Aug 9, 1995 | K951291 | OSTEONICS RESTORATION MONOLITHIC HIP STEM Osteonics Corp. | MEH |
| Jun 6, 1995 | K941366 | OSTEONICS OMNIFIT AD-HA HIP STEM SERIES Osteonics Corp. | MEH |
| May 25, 1995 | K945844 | DEPUY CDH PROSTHESIS Depuy, Inc. | MEH |
| Apr 10, 1995 | K946234 | OSTEONICS(R) RESTORATION MONOLITHIC II HIP STEM SERIES Osteonics Corp. | MEH |
| Apr 10, 1995 | K944836 | OSTEONICS RESTORATION MONOLITHIC II HIP STEM SERIES Osteonics Corp. | MEH |
| Mar 17, 1995 | K945691 | OSTEONICS(R) THREADED HA ACETABULAR SHELLS Osteonics Corp. | MEH |
| Mar 15, 1995 | K942900 | OSTEONICS SECURE-FIT AD-HA ACETABULAR COMPONENT SYSTEM Osteonics Corp. | MEH |
| Mar 6, 1995 | K943957 | RESTORATION HA ACETABULAR CUP SERIES Osteonics Corp. | MEH |
| Nov 2, 1994 | K942891 | SUMMIT TOTAL HIP SYSTEM Kirschner Medical Corp. | MEH |
| Sep 1, 1994 | K932017 | TECHMEDICA CONTINUUM HIP WITH HA COATING Techmedica, Inc. | MEH |
| Jul 22, 1994 | K935696 | ETEX HA HIP REPLACEMENT SYSTEM Etex Corp. | MEH |
| Jul 22, 1994 | K934729 | UFC HIP STEM COMPONENTS: HYDROXYLAPATITE COATED Implantology Corp. | MEH |
| Jul 13, 1994 | K935990 | F-220 PRESS-FIT FEMORAL HIP STEM SYSTEM Implex Corp. | MEH |
| Jul 13, 1994 | K935453 | CONSENSUS(TM) HIP SYSTEM-HA COATED TIANIUM FEM STEM U.S. Medical Products, Inc. | MEH |
| Apr 5, 1994 | K922613 | CL HIP STEM H/A COATED Lima Intl. Corp. | MEH |
| Mar 17, 1994 | K922621 | HA TI-FIT ACETABULAR AND FEMORAL COMPONENT Smith & Nephew Richards, Inc. | MEH |
| Feb 14, 1994 | K915655 | STABILITY FEMORAL PROSTHESIS W/HAP Depuy, Inc. | MEH |
| Nov 8, 1993 | K925607 | HA ANATOMIC HIP PROSTH W/TI-NIDIUM SURF HARD PROCE Zimmer, Inc. | MEH |
| Oct 22, 1993 | K926299 | CONTOUR FEMORAL HIP STEM W/HYDROAPATITE COATING Depuy, Inc. | MEH |
| Oct 15, 1993 | K926134 | H-220 PRESS-FIT ACETABULAR CUP SYSTEM Implex Corp. | MEH |
| May 5, 1993 | K920969 | HYDROXYLAPATITE INFINITY(R) Dow Corning Wright | MEH |
| Dec 24, 1992 | K915190 | PERFECTA TOTAL HIP SYSTEM, HA COATED Orthomet, Inc. | MEH |
| Aug 7, 1992 | K921672 | INTER-HA HIP PROSTHESIS Kirschner Medical Corp. | MEH |
| May 28, 1992 | K915617 | LSF HA COATED FEMORAL HIP Implant Technology, Inc. | MEH |
| Feb 3, 1992 | K915350 | HYDROXYAPATITE INFINITY TROCHANTERIC MODULE Dow Corning Wright | MEH |
| Feb 3, 1992 | K914843 | KINAMED ATH-HA & ATH-HA LONG TOTAL HIP Kinamed, Inc. | MEH |
| Dec 30, 1991 | K912713 | S-ROM ZT HA PROXIMAL FEMORAL SLEEVE Joint Medical Products Corp. | MEH |
| Dec 9, 1991 | K913916 | HYDROXYLAPATITE COATED TI-FIT FEMORAL COMPONENT Smith & Nephew Richards, Inc. | MEH |
| Oct 11, 1991 | K912370 | HAP BIO-GROOVE TOTAL HIP PROSTH (BIO-INTERFACES) Biomet, Inc. | MEH |
| Oct 11, 1991 | K912369 | HAP BIO-GROOVE TOTAL HIP PROSTHESIS (BIO-COAT) Biomet, Inc. | MEH |
| Oct 4, 1991 | K912922 | DIMENSION-HA HIP PROSTHESIS Kirschner Medical Corp. | MEH |
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