The following data is part of a premarket notification filed by Fournitures Hospitalieres Industrie with the FDA for Alumina Head.
| Device ID | K042035 |
| 510k Number | K042035 |
| Device Name: | ALUMINA HEAD |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
| Applicant | FOURNITURES HOSPITALIERES INDUSTRIE ZI DE KERNEVEZ-6 RUE NOBEL Quimper, FR 29000 |
| Contact | Christine Quendez |
| Correspondent | Christine Quendez FOURNITURES HOSPITALIERES INDUSTRIE ZI DE KERNEVEZ-6 RUE NOBEL Quimper, FR 29000 |
| Product Code | LZO |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-07-29 |
| Decision Date | 2004-11-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03661489538339 | K042035 | 000 |
| 03661489538322 | K042035 | 000 |
| 03661489538315 | K042035 | 000 |
| 03661489538308 | K042035 | 000 |
| 03661489538292 | K042035 | 000 |
| 03661489538285 | K042035 | 000 |
| 03661489069741 | K042035 | 000 |