Hayes Medical, Inc.
El Dorado Hills, CA, US
Hayes Medical, Inc. appears in FDA device records in El Dorado Hills, CA. FDA records list 12 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 12
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 12 510(k) clearances for Hayes Medical, Inc. between 1995 and 2007. The busiest year on record is 2002, with 2. The most recent is 2007, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1995 | 1 |
| 1997 | 1 |
| 1998 | 1 |
| 2000 | 1 |
| 2001 | 1 |
| 2002 | 2 |
| 2003 | 2 |
| 2006 | 2 |
| 2007 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K070061 | 36MM COCR FEMORAL HEAD AND 36MM ACETABULAR INSERT | LWJ | Substantially Equivalent | |
| K062383 | UNISYN HA PLASMA MODULAR HIP | LWJ | Substantially Equivalent | |
| K060635 | CONSENSUS ACETABULAR SHELL SYSTEM | LPH | Substantially Equivalent | |
| K030151 | CONSENSUS HIP SYSTEM, UNISYN HIP SYSTEM | LZO | Substantially Equivalent | |
| K030205 | CONSENSUS UNIPOLAR HEAD, COCR | KWL | Substantially Equivalent | |
| K021466 | CONSENSUS ACETABULAR INSERT, CROSS-LINKED POLYETHYLENE | LPH | Substantially Equivalent | |
| K020153 | CONSENSUS ACETABLAR SHELL, TI COATED | LPH | Substantially Equivalent | |
| K003649 | TRITON HIP SYSTEM | LWJ | Substantially Equivalent | |
| K001456 | CONSENSUS KNEE SYSTEM | JWH | Substantially Equivalent | |
| K983004 | CONSENSUS FEMORAL COMPONENT, POROUS, COCR/TI | JWH | Substantially Equivalent | |
| K964395 | PATIENT SPECIFIC IMPLANT (PSI) HIP FEMORAL COMPONENT | LZO | Substantially Equivalent | |
| K953198 | CORTICELLOUS BONE SCREW | HWC | Substantially Equivalent for Some Indications |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- KWLProsthesis, Hip, Hemi-, Femoral, Metal
- LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
- LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
- LWJProsthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented
- JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
- HWCScrew, Fixation, Bone
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
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Data as of , FDA export datePage updated Source: openFDA, public domain