The following data is part of a premarket notification filed by Osteonics Corp. with the FDA for Omnifit Total Knee Series Iii,iv & Post. Stab. Fem.
| Device ID | K884410 |
| 510k Number | K884410 |
| Device Name: | OMNIFIT TOTAL KNEE SERIES III,IV & POST. STAB. FEM |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | OSTEONICS CORP. 59 ROUTE 17 Allendale, NJ 07401 -1677 |
| Contact | Michael B Sheldon |
| Correspondent | Michael B Sheldon OSTEONICS CORP. 59 ROUTE 17 Allendale, NJ 07401 -1677 |
| Product Code | JWH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-10-20 |
| Decision Date | 1989-01-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327035261 | K884410 | 000 |
| 07613327035070 | K884410 | 000 |
| 07613327035063 | K884410 | 000 |
| 07613327035056 | K884410 | 000 |
| 07613327035049 | K884410 | 000 |
| 07613327035032 | K884410 | 000 |
| 07613327035025 | K884410 | 000 |
| 07613327035018 | K884410 | 000 |
| 07613327035001 | K884410 | 000 |
| 07613327034998 | K884410 | 000 |
| 07613327034981 | K884410 | 000 |
| 07613327034974 | K884410 | 000 |
| 07613327034967 | K884410 | 000 |
| 07613327034950 | K884410 | 000 |
| 07613327034943 | K884410 | 000 |
| 07613327034936 | K884410 | 000 |
| 07613327035087 | K884410 | 000 |
| 07613327035094 | K884410 | 000 |
| 07613327035100 | K884410 | 000 |
| 07613327035254 | K884410 | 000 |
| 07613327035247 | K884410 | 000 |
| 07613327035230 | K884410 | 000 |
| 07613327035223 | K884410 | 000 |
| 07613327035216 | K884410 | 000 |
| 07613327035209 | K884410 | 000 |
| 07613327035193 | K884410 | 000 |
| 07613327035186 | K884410 | 000 |
| 07613327035179 | K884410 | 000 |
| 07613327035162 | K884410 | 000 |
| 07613327035155 | K884410 | 000 |
| 07613327035148 | K884410 | 000 |
| 07613327035131 | K884410 | 000 |
| 07613327035124 | K884410 | 000 |
| 07613327035117 | K884410 | 000 |
| 07613327034929 | K884410 | 000 |