FDA Product Code
FDA Product Code JDG — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Orthopedic
- 21 CFR Citation
- 888.3360
510(k) Clearances — 59 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K212431 | Biomet Answer/Impact/Integral Distal Centralizer/Centering Sleeve | Biomet, Inc. | 2022-02-07 | Traditional | PDF ↗ |
| K193546 | Distal Centralizers | Biomet, Inc. | 2020-09-25 | Traditional | PDF ↗ |
| K173499 | Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral Heads | Stryker Orthopaedics | 2018-03-19 | Traditional | PDF ↗ |
| K001984 | PROGENY FORGED COCR CEMENTED FEMORAL COMPONENT | Stelkast Company | 2000-09-27 | Traditional | PDF ↗ |
| K992234 | THE TAPER-FIT TOTAL HIP SYSTEM | Corin USA | 1999-11-10 | Traditional | PDF ↗ |
| K962002 | AURA HIP SYSTEM CALCAR REPLACEMENT FEMORAL STEM | Exactech, Inc. | 1996-08-08 | Traditional | PDF ↗ |
| K955171 | NEXLOCK FEMORAL STEM | Nexmed, Inc. | 1996-02-09 | Traditional | PDF ↗ |
| K953653 | LUBINUS SP II HIP SYSTEM | Turnkey Intergration USA, Inc. | 1995-11-06 | Traditional | PDF ↗ |
| K953067 | HIP FRACTURE STEM FENESTRATION PLUG | Howmedica Corp. | 1995-08-21 | Traditional | PDF ↗ |
| K945783 | ORTHOMET TITANIUM HYBRID FEMORAL STEM | Orthomet, Inc. | 1995-05-30 | Traditional | PDF ↗ |
| K951083 | PROFORM CEMENTED FEMORAL COMPONENT | Stelkast Company | 1995-05-22 | Traditional | PDF ↗ |
| K942479 | INTEGRAL CO-CR FEMORAL COMPONENT | Biomet, Inc. | 1994-09-20 | Traditional | PDF ↗ |
| K942027 | IMPACT CO-CR 1-PIECE FEMORAL COMPONENT | Biomet, Inc. | 1994-09-19 | Traditional | PDF ↗ |
| K942028 | RX90 FEMORAL COMPONENT | Biomet, Inc. | 1994-09-19 | Traditional | PDF ↗ |
| K931194 | CO-CR ANSWER FEMORAL COMPONENT | Biomet, Inc. | 1994-05-05 | Traditional | PDF ↗ |
| K935078 | S-ROM TOTAL HIP REPLACEMENT SYSTEM | Joint Medical Products Corp. | 1994-03-09 | Traditional | PDF ↗ |
| K933871 | BRIDGE(TM) HIP SYSTEM | Wrightmedicaltechnologyinc | 1994-02-23 | Traditional | PDF ↗ |
| K915385 | PPC HIP STEM COMPONENT | Implantology Corp. | 1993-05-17 | Traditional | PDF ↗ |
| K915391 | FPC HIP STEM COMPONENT | Implantology Corp. | 1993-04-30 | Traditional | PDF ↗ |
| K924099 | UFC HIP STEM COMPONENT | Implantology Corp. | 1993-04-30 | Traditional | PDF ↗ |
| K915787 | STABILITY HIP STEM WITH POROCOAT | Depuy, Inc. | 1993-04-29 | Traditional | PDF ↗ |
| K922682 | AMERICANA HIP PROTHESIS | Osteo Technology, Inc. | 1993-03-16 | Traditional | PDF ↗ |
| K911595 | INFINITY(TM) POROUS-COATED TROCHANTERIC MODULE | Dow Corning Wright | 1991-07-12 | Traditional | PDF ↗ |
| K874868 | OPTI-FIX COLLARED FEMORAL COMPONENTS | Richards Medical Co., Inc. | 1988-01-26 | Traditional | PDF ↗ |
| K874575 | PROXIMAL FEMORAL REPLACEMENT PROSTHESIS | Dow Corning Wright | 1988-01-07 | Traditional | PDF ↗ |
| K874100 | AML CALCAR FEMORAL PROSTHESIS | Depuy, Inc. | 1987-12-31 | Traditional | PDF ↗ |
| K873627 | CTI STRAIGHT STEM | Orthopedic Systems, Inc. | 1987-12-30 | Traditional | PDF ↗ |
| K874740 | WHITESIDE ORTHOLOC CALCAR REPLACEMENT HIP STEM PRO | Dow Corning Wright | 1987-12-18 | Traditional | PDF ↗ |
| K874617 | THOMPSON HIP PROSTHESIS | Orthopedic Systems, Inc. | 1987-12-10 | Traditional | PDF ↗ |
| K873458 | HOWMEDICA PCA COLLARED FEMORAL STEM | Howmedica Corp. | 1987-09-23 | Traditional | PDF ↗ |
| K873089 | PRECISION HIP LONG STEM FEMORAL COMPONENT SYSTEM | Howmedica Corp. | 1987-09-16 | Traditional | PDF ↗ |
| K851566 | HOWMEDICA FEMORAL COMPONENT HIP SYS 6259 | Howmedica Corp. | 1985-07-30 | Traditional | PDF ↗ |
| K833468 | BDH UNIVERSAL HIP SYSTEM SURGEON | Carbomedics, Inc. | 1983-12-27 | Traditional | PDF ↗ |
| K812687 | BRIGHAM II TOTAL HIP SYSTEM | Hexcel Medical | 1981-10-02 | Traditional | PDF ↗ |
| K812669 | SEATTLE II TOTAL HIP SYSTEM | Hexcel Medical | 1981-10-02 | Traditional | PDF ↗ |
| K801006 | CHARNLEY DESIGN HIP PROSTHESIS | Colmed, Ltd. | 1980-05-20 | Traditional | PDF ↗ |
| K800051 | HEXCEL FEMORAL COMPONENT HIP PROSTHESIS | Hexcel Medical | 1980-01-28 | Traditional | PDF ↗ |
| K800050 | ANITOMIC TOTAL HIP SYSTEM | Hexcel Medical | 1980-01-24 | Traditional | PDF ↗ |
| K792329 | BIOPHASE IMPLANT MATERIAL | Richard'S Medical Equip., Inc. | 1980-01-23 | Traditional | PDF ↗ |
| K780773 | PROSTHESIS, HIP, CATHCART, SCHILLER MOD. | Depuy, Inc. | 1978-06-22 | Traditional | PDF ↗ |
| K780497 | SPHERISTEM TOTAL HIP PROSTHESIS | American Ortomed Corp. | 1978-06-14 | Traditional | PDF ↗ |
| K780357 | TITANIUM MULLER TOTAL HIP | Biomet, Inc. | 1978-04-05 | Traditional | PDF ↗ |
| K780329 | TOTAL HIP, NEW ENGLAND BAPTIST | Depuy, Inc. | 1978-03-17 | Traditional | PDF ↗ |
| K772120 | TOTAL HIP, CHARNELY TYPE | Depuy, Inc. | 1977-12-20 | Traditional | PDF ↗ |
| K770471 | KERBOULL-CHARNLEY CUP SPECIAL MODEL | Howmedica Corp. | 1977-03-24 | Traditional | PDF ↗ |
| K770473 | LAGRANGE LETOURNEL TOTAL HIP FEMORAL | Howmedica Corp. | 1977-03-17 | Traditional | PDF ↗ |
| K770219 | WATSON-FARRAR TOTAL HIP REPLACEMENT | Orthopedic Equipment Co., Inc. | 1977-02-17 | Traditional | PDF ↗ |
| K770184 | BI-CENTRIC ENDOPROSTHESES | Howmedica Corp. | 1977-02-08 | Traditional | PDF ↗ |
| K770161 | MICROFENESTRATED HIP REPLACEMENT COMPON. | Medishield, Inc. | 1977-01-26 | Traditional | PDF ↗ |
| K761146 | SPARBARO TYPE TOTAL HIP | Orthopedic Equipment Co., Inc. | 1976-12-16 | Traditional | PDF ↗ |
| K761243 | 12-9170 SERIES II TOTAL HIP | Richardo Manufacturing Co. | 1976-12-16 | Traditional | PDF ↗ |
| K761003 | CHARNLEY CONGENITAL HIP FEMUR (85-3061) | Codman & Shurtleff, Inc. | 1976-11-23 | Traditional | PDF ↗ |
| K761002 | CHARNLEY CONGENITAL HIP FEMUR (85-3060) | Codman & Shurtleff, Inc. | 1976-11-23 | Traditional | PDF ↗ |
| K760974 | CHARNLEY FEMORAL COMPONENT | Codman & Shurtleff, Inc. | 1976-11-16 | Traditional | PDF ↗ |
| K760976 | CHARNLEY REVISION SET | Codman & Shurtleff, Inc. | 1976-11-16 | Traditional | PDF ↗ |
| K760651 | TOTAL HIP REPLACEMENT,LAGRANGE-LETOURNEL | Orthopedic Equipment Co., Inc. | 1976-10-05 | Traditional | PDF ↗ |
| K760108 | PROSTHESIS, TOTAL HIP-TEST CUP | Orthopedic Equipment Co., Inc. | 1976-07-20 | Traditional | PDF ↗ |
| K760107 | PROSTHESIS, TOTAL HIP-TEST FEMORAL | Orthopedic Equipment Co., Inc. | 1976-07-20 | Traditional | PDF ↗ |
| K760106 | PROSTHESIS, TOTAL HIP-FEMORAL | Orthopedic Equipment Co., Inc. | 1976-07-20 | Traditional | PDF ↗ |
Product code JDG · Class II · Orthopedic. Data: openFDA.