The following data is part of a premarket notification filed by Howmedica Osteonics Corp. with the FDA for V-40/c-taper Adapter Sleeve.
| Device ID | K003379 |
| 510k Number | K003379 |
| Device Name: | V-40/C-TAPER ADAPTER SLEEVE |
| 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 | 2000-11-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327016468 | K003379 | 000 |