510(k) K092198
- Device
- CORMET CEMENTLESS RESURFACING FEMORAL HEAD
- Applicant
- CORIN USA
- 510(k) number
- K092198
- Product code
- KXA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2010-04-15
- Date received
- 2009-07-21
- Regulation
- 888.3400
- Classification name
- Prosthesis, Hip, Femoral, Resurfacing
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- ASHLEA BOWEN
- Address
- 10500 University Center Dr. Suite 190 Tampa FL US 33612 33612
FDA Registration Numbers#
- 9614209
- 2245304
- 1450662
- 1047843
- 1222928
- 3020162561
- 1825034
- 3013176080
- 9613350
- 3004153896
- 3015207155
- 3035366890
- 2244478
- 1220477
- 1526534
- 3006085220
- 3010536692
- 1218882
- 3004154314
- 1822565
- 3014302784
- 1828464
- 1833506
- 3005061536
- 1529009
Source Documents#
Other 510(k) Records For Product Code KXA #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K201219 | Biocore9 Femoral Head Resurfacing Component | Biocore9, LLC | 2021-01-19 |
| K082673 | CONSERVE PRESSFIT FEMORAL COMPONENT | Wrightmedicaltechnologyinc | 2008-12-12 |
| K071053 | RECAP HA PRESS-FIT FEMORAL RESURFACING HEAD | Biomet, Inc. | 2007-06-29 |
| K070292 | DUROM HIP RESURFACING SYSTEM, FEMORAL COMPONENTS | Zimmer GmbH | 2007-04-26 |
| K062960 | CONSERVE FEMORAL RESURFACING COMPONENT | Wrightmedicaltechnologyinc | 2006-12-01 |
| K043542 | BIOPRO TARA FEMORAL RESURFACING COMPONENT | Biopro, Inc. | 2005-05-18 |
| K032659 | DEPUY ASR RESURFACING FEMORAL HEADS | DePuy Orthopaedics, Inc. | 2003-12-04 |
| K023188 | PRESS-FIT HEAD RESURFACING DEVICE | Biomet Orthopedics, Inc. | 2002-12-11 |
| K021549 | CONTOURED ARTICULAR PROSTHESIS (CAP) FEMORAL HEAD RESURFACING SYSTEM | Std Mfg., Inc. | 2002-08-01 |
| K021799 | CEMENTED FEMORAL HEAD RESURFING DEVICE | Biomet Orthopedics, Inc. | 2002-06-26 |
| K994153 | CORMET 2000 HEMI HIP METALLIC RESURFACING PROSTHESIS | Corin USA | 2000-02-25 |
| K983452 | NELSON RESURFACING HEAD | Biomet, Inc. | 1998-12-03 |
| K950998 | MODUILAR UNIPOLAR | Intermedics Orthopedics | 1995-04-13 |
| K944752 | ORTHOMET RESURFACING FEMORAL COMPONENT | Orthomet, Inc. | 1994-12-28 |
| K904870 | MODIFIED NEW JERSEY FEMORAL HIP RESURFACING COMPON | Endotec, Inc. | 1991-05-23 |
Legacy Summary#
summary
FDA Review#
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