FDA Product Code
FDA Product Code KXA — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Orthopedic
- 21 CFR Citation
- 888.3400
510(k) Clearances — 23 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K201219 | Biocore9 Femoral Head Resurfacing Component | Biocore9, LLC | 2021-01-19 | Traditional | PDF ↗ |
| K092198 | CORMET CEMENTLESS RESURFACING FEMORAL HEAD | Corin USA | 2010-04-15 | Traditional | PDF ↗ |
| K082673 | CONSERVE PRESSFIT FEMORAL COMPONENT | Wrightmedicaltechnologyinc | 2008-12-12 | Traditional | PDF ↗ |
| K071053 | RECAP HA PRESS-FIT FEMORAL RESURFACING HEAD | Biomet, Inc. | 2007-06-29 | Special | PDF ↗ |
| K070292 | DUROM HIP RESURFACING SYSTEM, FEMORAL COMPONENTS | Zimmer GmbH | 2007-04-26 | Traditional | PDF ↗ |
| K062960 | CONSERVE FEMORAL RESURFACING COMPONENT | Wrightmedicaltechnologyinc | 2006-12-01 | Special | PDF ↗ |
| K043542 | BIOPRO TARA FEMORAL RESURFACING COMPONENT | Biopro, Inc. | 2005-05-18 | Traditional | PDF ↗ |
| K032659 | DEPUY ASR RESURFACING FEMORAL HEADS | DePuy Orthopaedics, Inc. | 2003-12-04 | Traditional | PDF ↗ |
| K023188 | PRESS-FIT HEAD RESURFACING DEVICE | Biomet Orthopedics, Inc. | 2002-12-11 | Traditional | PDF ↗ |
| K021549 | CONTOURED ARTICULAR PROSTHESIS (CAP) FEMORAL HEAD RESURFACING SYSTEM | Std Mfg., Inc. | 2002-08-01 | Traditional | PDF ↗ |
| K021799 | CEMENTED FEMORAL HEAD RESURFING DEVICE | Biomet Orthopedics, Inc. | 2002-06-26 | Special | PDF ↗ |
| K994153 | CORMET 2000 HEMI HIP METALLIC RESURFACING PROSTHESIS | Corin USA | 2000-02-25 | Traditional | PDF ↗ |
| K983452 | NELSON RESURFACING HEAD | Biomet, Inc. | 1998-12-03 | Traditional | PDF ↗ |
| K950998 | MODUILAR UNIPOLAR | Intermedics Orthopedics | 1995-04-13 | Traditional | PDF ↗ |
| K944752 | ORTHOMET RESURFACING FEMORAL COMPONENT | Orthomet, Inc. | 1994-12-28 | Traditional | PDF ↗ |
| K904870 | MODIFIED NEW JERSEY FEMORAL HIP RESURFACING COMPON | Endotec, Inc. | 1991-05-23 | Traditional | PDF ↗ |
| K894604 | BIOPRO PROXIMAL FEMORAL ARTICULAR REPLACEMENT | Biopro, Inc. | 1989-11-17 | Traditional | PDF ↗ |
| K892398 | BIPOLAR HIP SYSTEM | Orthomet, Inc. | 1989-05-23 | Traditional | PDF ↗ |
| K883212 | LSF (R) TOTAL HIP SYSTEM - BIPOLAR COMPONENT | Implant Technology, Inc. | 1988-11-22 | Traditional | PDF ↗ |
| K842233 | NEW JERSEY FEMORAL RESURFACING COMPONENT | Endomedics, Inc. | 1984-07-20 | Traditional | PDF ↗ |
| K792200 | TILLMAN HIP RESURFACING REPLACEMT PROS. | Waldemar Link GmbH & Co. KG | 1979-12-05 | Traditional | PDF ↗ |
| K781490 | TILLMAN HIPSURFACE REPLACEMENT | Waldemar Link GmbH & Co. KG | 1978-09-20 | Traditional | PDF ↗ |
| K761324 | RESURFACE PROSTHESES FOR HIP JOINT | Holco Instrument Corp. | 1977-01-05 | Traditional | PDF ↗ |
Product code KXA · Class II · Orthopedic. Data: openFDA.