The following data is part of a premarket notification filed by Howmedica Osteonics Corp. with the FDA for 36mm C-taper Femoral Head Components (lfit And Non-lfit).
| Device ID | K021310 |
| 510k Number | K021310 |
| Device Name: | 36MM C-TAPER FEMORAL HEAD COMPONENTS (LFIT AND NON-LFIT) |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
| Applicant | HOWMEDICA OSTEONICS CORP. 59 ROUTE 17 SOUTH Allendale, NJ 07401 -1677 |
| Contact | Jennifer A Daudelin |
| Correspondent | Jennifer A Daudelin HOWMEDICA OSTEONICS CORP. 59 ROUTE 17 SOUTH Allendale, NJ 07401 -1677 |
| Product Code | JDI |
| Subsequent Product Code | KWY |
| Subsequent Product Code | LWJ |
| CFR Regulation Number | 888.3350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-04-25 |
| Decision Date | 2002-05-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327072389 | K021310 | 000 |
| 07613327072372 | K021310 | 000 |
| 07613327072365 | K021310 | 000 |
| 07613327072358 | K021310 | 000 |