FDA Product Code
FDA Product Code MEH — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Orthopedic
- 21 CFR Citation
- 888.3353
510(k) Clearances — 160 records · page 2 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K990197 | MODULUS COMPATIBLE STABILITY (MCS)-HA TOTAL HIP SYSTEM | Exactech, Inc. | 1999-02-04 | Special | PDF ↗ |
| K983382 | OSTEONICS HA GENERATION II ACETABULAR COMPONENT SYSTEM | Osteonics Corp. | 1998-12-11 | Traditional | PDF ↗ |
| K983870 | OSTEONICS RESTORATION HA HIP STEMS | Osteonics Corp. | 1998-12-02 | Special | PDF ↗ |
| K982032 | OSTEONICS OMNIFIT HA HIP STEM SERIES, OSTEONICS SECUR-FIT HA HIP STEM SERIES, OSTEONICS PRIMARY SECUR-FIT PLUS HIP STEMS | Osteonics Corp. | 1998-07-09 | Special | PDF ↗ |
| K980766 | OSTEONICS ANTEVERTED NECK HA HIP STEMS | Osteonics Corp. | 1998-05-27 | Traditional | PDF ↗ |
| K964878 | ESOP S/C FEMORAL STEM | Fournitures Hospitalieres | 1998-03-05 | Traditional | PDF ↗ |
| K971523 | DISTALLY FIXED HIP STEM | Sulzer Orthopedics, Inc. | 1997-10-01 | Traditional | PDF ↗ |
| K961732 | KAR | Landos, Inc. | 1997-07-08 | Traditional | PDF ↗ |
| K971422 | OSTEONICS ACETABULAR WEDGE SYSTEM | Osteonics Corp. | 1997-05-22 | Traditional | PDF ↗ |
| K970394 | OSTEONICS NORMALIZED AD-HA ACETABULAR COMPONENT SYSTEM | Osteonics Corp. | 1997-04-22 | Traditional | PDF ↗ |
| K961388 | ATLAS III ACETABULAR CUP | Fournitures Hospitalieres | 1997-04-03 | Traditional | PDF ↗ |
| K970337 | HA GLOBAL TAPER (GT) TAPERED HIP STEM | Smith & Nephew, Inc., Orthopaedic Div. | 1997-02-28 | Traditional | PDF ↗ |
| K963959 | OSTEONICS MODULAR ACETABULAR CUP (HA-COATED VERSION) | Osteonics Corp. | 1996-12-19 | Traditional | PDF ↗ |
| K954800 | APR HIP SYS W/CAL-COATED CAN STR TITANIUM (CSTI) | Intermedics Orthopedics | 1996-04-25 | Traditional | PDF ↗ |
| K955305 | PCA +15MM MODULAR FEMORAL HEAD | Howmedica Corp. | 1996-01-18 | Traditional | PDF ↗ |
| K951517 | OSTEONICS SECUR-FIT HA PLUS HIP STEM SERIES | Osteonics Corp. | 1996-01-17 | Traditional | PDF ↗ |
| K954023 | OSTEONICS SECUR-FIT HA PSL EXTRA ACETABULAR COMPONENT SYSTEM | Osteonics Corp. | 1995-11-22 | Traditional | PDF ↗ |
| K951671 | OSTEONICS RESTORATION MONOLITHIC II SLOTTED HIP STEM SERIES | Osteonics Corp. | 1995-09-06 | Traditional | PDF ↗ |
| K951932 | OSTEONICS RESTORATION MONOLITHIC II HIP STEM SERIES | Osteonics Corp. | 1995-09-01 | Traditional | PDF ↗ |
| K951291 | OSTEONICS RESTORATION MONOLITHIC HIP STEM | Osteonics Corp. | 1995-08-09 | Traditional | PDF ↗ |
| K941366 | OSTEONICS OMNIFIT AD-HA HIP STEM SERIES | Osteonics Corp. | 1995-06-06 | Traditional | PDF ↗ |
| K945844 | DEPUY CDH PROSTHESIS | Depuy, Inc. | 1995-05-25 | Traditional | PDF ↗ |
| K944836 | OSTEONICS RESTORATION MONOLITHIC II HIP STEM SERIES | Osteonics Corp. | 1995-04-10 | Traditional | PDF ↗ |
| K946234 | OSTEONICS(R) RESTORATION MONOLITHIC II HIP STEM SERIES | Osteonics Corp. | 1995-04-10 | Traditional | PDF ↗ |
| K945691 | OSTEONICS(R) THREADED HA ACETABULAR SHELLS | Osteonics Corp. | 1995-03-17 | Traditional | PDF ↗ |
| K942900 | OSTEONICS SECURE-FIT AD-HA ACETABULAR COMPONENT SYSTEM | Osteonics Corp. | 1995-03-15 | Traditional | PDF ↗ |
| K943957 | RESTORATION HA ACETABULAR CUP SERIES | Osteonics Corp. | 1995-03-06 | Traditional | PDF ↗ |
| K942891 | SUMMIT TOTAL HIP SYSTEM | Kirschner Medical Corp. | 1994-11-02 | Traditional | PDF ↗ |
| K932017 | TECHMEDICA CONTINUUM HIP WITH HA COATING | Techmedica, Inc. | 1994-09-01 | Traditional | PDF ↗ |
| K934729 | UFC HIP STEM COMPONENTS: HYDROXYLAPATITE COATED | Implantology Corp. | 1994-07-22 | Traditional | PDF ↗ |
| K935696 | ETEX HA HIP REPLACEMENT SYSTEM | Etex Corp. | 1994-07-22 | Traditional | PDF ↗ |
| K935453 | CONSENSUS(TM) HIP SYSTEM-HA COATED TIANIUM FEM STEM | U.S. Medical Products, Inc. | 1994-07-13 | Traditional | PDF ↗ |
| K935990 | F-220 PRESS-FIT FEMORAL HIP STEM SYSTEM | Implex Corp. | 1994-07-13 | Traditional | PDF ↗ |
| K922613 | CL HIP STEM H/A COATED | Lima Intl. Corp. | 1994-04-05 | Traditional | PDF ↗ |
| K922621 | HA TI-FIT ACETABULAR AND FEMORAL COMPONENT | Smith & Nephew Richards, Inc. | 1994-03-17 | Traditional | PDF ↗ |
| K915655 | STABILITY FEMORAL PROSTHESIS W/HAP | Depuy, Inc. | 1994-02-14 | Traditional | PDF ↗ |
| K925607 | HA ANATOMIC HIP PROSTH W/TI-NIDIUM SURF HARD PROCE | Zimmer, Inc. | 1993-11-08 | Traditional | PDF ↗ |
| K926299 | CONTOUR FEMORAL HIP STEM W/HYDROAPATITE COATING | Depuy, Inc. | 1993-10-22 | Traditional | PDF ↗ |
| K926134 | H-220 PRESS-FIT ACETABULAR CUP SYSTEM | Implex Corp. | 1993-10-15 | Traditional | PDF ↗ |
| K920969 | HYDROXYLAPATITE INFINITY(R) | Dow Corning Wright | 1993-05-05 | Traditional | PDF ↗ |
| K915190 | PERFECTA TOTAL HIP SYSTEM, HA COATED | Orthomet, Inc. | 1992-12-24 | Traditional | PDF ↗ |
| K921672 | INTER-HA HIP PROSTHESIS | Kirschner Medical Corp. | 1992-08-07 | Traditional | PDF ↗ |
| K915617 | LSF HA COATED FEMORAL HIP | Implant Technology, Inc. | 1992-05-28 | Traditional | PDF ↗ |
| K915350 | HYDROXYAPATITE INFINITY TROCHANTERIC MODULE | Dow Corning Wright | 1992-02-03 | Traditional | PDF ↗ |
| K914843 | KINAMED ATH-HA & ATH-HA LONG TOTAL HIP | Kinamed, Inc. | 1992-02-03 | Traditional | PDF ↗ |
| K912713 | S-ROM ZT HA PROXIMAL FEMORAL SLEEVE | Joint Medical Products Corp. | 1991-12-30 | Traditional | PDF ↗ |
| K913916 | HYDROXYLAPATITE COATED TI-FIT FEMORAL COMPONENT | Smith & Nephew Richards, Inc. | 1991-12-09 | Traditional | PDF ↗ |
| K912370 | HAP BIO-GROOVE TOTAL HIP PROSTH (BIO-INTERFACES) | Biomet, Inc. | 1991-10-11 | Traditional | PDF ↗ |
| K912369 | HAP BIO-GROOVE TOTAL HIP PROSTHESIS (BIO-COAT) | Biomet, Inc. | 1991-10-11 | Traditional | PDF ↗ |
| K912922 | DIMENSION-HA HIP PROSTHESIS | Kirschner Medical Corp. | 1991-10-04 | Traditional | PDF ↗ |
| K912452 | HA MCCUTCHEN SLT HIP SYSTEM | Dow Corning Wright | 1991-10-04 | Traditional | PDF ↗ |
| K912263 | HA ANATOMIC HIP PROSTH W/ TI-NIDIUM SURF HARD PROC | Zimmer, Inc. | 1991-08-29 | Traditional | PDF ↗ |
| K911728 | OMNIFIT(R) EPF DUAL GEOMTRY/RADIUS/THREAD ACETAB C | Osteonics Corp. | 1991-08-16 | Traditional | PDF ↗ |
| K912654 | OMNIFIT EPF DUAL GEOMETRY ACETABULAR CUP | Osteonics Corp. | 1991-08-16 | Traditional | PDF ↗ |
| K912395 | HOWMEDICA PRECIS OSTEOLOCK FEM COMP W/HYDRO COAT | Howmedica Corp. | 1991-07-24 | Traditional | PDF ↗ |
| K911585 | OMNIFIT II EPF HIP STEM SERIES | Osteonics Corp. | 1991-07-01 | Traditional | PDF ↗ |
| K910156 | HYDROXYAPATITE COATED PROFILE(R) HIP STEM | Depuy, Inc. | 1991-06-07 | Traditional | PDF ↗ |
| K910755 | PREMIER-TOTAL(TM) HIP WITH CALCITITE(R) COATING | Intermedics Orthopedics | 1991-03-26 | Traditional | PDF ↗ |
| K905781 | APR AND APR II PRESS-FIT UNIVERSAL HIP SYSTEM | Intermedics Orthopedics | 1991-03-04 | Traditional | PDF ↗ |
| K896047 | THE OMNIFIT EPF HIP JOINT FEMORAL STEM | Osteonics Corp. | 1990-12-20 | Traditional | PDF ↗ |
Product code MEH · Class II · Orthopedic. Data: openFDA.