The following data is part of a premarket notification filed by Howmedica Osteonics Corp. with the FDA for Omnifit Hfx Hip Stem Series.
| Device ID | K031744 |
| 510k Number | K031744 |
| Device Name: | OMNIFIT HFX HIP STEM SERIES |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
| Applicant | HOWMEDICA OSTEONICS CORP. 59 ROUTE 17 SOUTH Allendale, NJ 07401 -1677 |
| Contact | Debra Bing |
| Correspondent | Debra Bing HOWMEDICA OSTEONICS CORP. 59 ROUTE 17 SOUTH Allendale, NJ 07401 -1677 |
| Product Code | JDI |
| Subsequent Product Code | KWL |
| Subsequent Product Code | LWJ |
| CFR Regulation Number | 888.3350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-06-05 |
| Decision Date | 2003-08-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327023572 | K031744 | 000 |
| 07613327023435 | K031744 | 000 |
| 07613327023442 | K031744 | 000 |
| 07613327023459 | K031744 | 000 |
| 07613327023480 | K031744 | 000 |
| 07613327023497 | K031744 | 000 |
| 07613327023503 | K031744 | 000 |
| 07613327023510 | K031744 | 000 |
| 07613327023527 | K031744 | 000 |
| 07613327023534 | K031744 | 000 |
| 07613327023541 | K031744 | 000 |
| 07613327023558 | K031744 | 000 |
| 07613327023428 | K031744 | 000 |