Company ยท US
Hayes Medical, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1995 to 2007. Name variants (Inc, Corp, punctuation) are merged.
12510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | 3 |
| LWJ | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented | 3 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | 2 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | 2 |
| HWC | Screw, Fixation, Bone | 1 |
| KWL | Prosthesis, Hip, Hemi-, Femoral, Metal | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 31, 2007 | K070061 | 36MM COCR FEMORAL HEAD AND 36MM ACETABULAR INSERT Hayes Medical, Inc. | LWJ |
| Dec 21, 2006 | K062383 | UNISYN HA PLASMA MODULAR HIP Hayes Medical, Inc. | LWJ |
| Apr 28, 2006 | K060635 | CONSENSUS ACETABULAR SHELL SYSTEM Hayes Medical, Inc. | LPH |
| Apr 10, 2003 | K030151 | CONSENSUS HIP SYSTEM, UNISYN HIP SYSTEM Hayes Medical, Inc. | LZO |
| Apr 1, 2003 | K030205 | CONSENSUS UNIPOLAR HEAD, COCR Hayes Medical, Inc. | KWL |
| Jul 24, 2002 | K021466 | CONSENSUS ACETABULAR INSERT, CROSS-LINKED POLYETHYLENE Hayes Medical, Inc. | LPH |
| Apr 15, 2002 | K020153 | CONSENSUS ACETABLAR SHELL, TI COATED Hayes Medical, Inc. | LPH |
| Feb 23, 2001 | K003649 | TRITON HIP SYSTEM Hayes Medical, Inc. | LWJ |
| Aug 7, 2000 | K001456 | CONSENSUS KNEE SYSTEM Hayes Medical, Inc. | JWH |
| Nov 25, 1998 | K983004 | CONSENSUS FEMORAL COMPONENT, POROUS, COCR/TI Hayes Medical, Inc. | JWH |
| Jan 27, 1997 | K964395 | PATIENT SPECIFIC IMPLANT (PSI) HIP FEMORAL COMPONENT Hayes Medical, Inc. | LZO |
| Nov 24, 1995 | K953198 | CORTICELLOUS BONE SCREW Hayes Medical, Inc. | HWC |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||