The following data is part of a premarket notification filed by Howmedica Osteonics Corp. with the FDA for Osteonics Alumina C-taper Head.
| Device ID | K003391 |
| 510k Number | K003391 |
| Device Name: | OSTEONICS ALUMINA C-TAPER HEAD |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
| Applicant | HOWMEDICA OSTEONICS CORP. 59 ROUTE 17 SOUTH Allendale, NJ 07401 -1677 |
| Contact | Karen Ariemma |
| Correspondent | Karen Ariemma HOWMEDICA OSTEONICS CORP. 59 ROUTE 17 SOUTH Allendale, NJ 07401 -1677 |
| Product Code | LZO |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-10-31 |
| Decision Date | 2000-11-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04546540195647 | K003391 | 000 |
| 04546540195616 | K003391 | 000 |
| 04546540195586 | K003391 | 000 |