The following data is part of a premarket notification filed by Osteonics Corp. with the FDA for Osteonics 7000 Series Total Knee Tibial Components.
| Device ID | K910990 |
| 510k Number | K910990 |
| Device Name: | OSTEONICS 7000 SERIES TOTAL KNEE TIBIAL COMPONENTS |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | OSTEONICS CORP. 59 ROUTE 17 Allendale, NJ 07401 -1677 |
| Contact | Pat Kramer |
| Correspondent | Pat Kramer 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 | 1991-03-07 |
| Decision Date | 1991-06-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327033397 | K910990 | 000 |
| 07613327031409 | K910990 | 000 |
| 07613327031416 | K910990 | 000 |
| 07613327031423 | K910990 | 000 |
| 07613327033328 | K910990 | 000 |
| 07613327033335 | K910990 | 000 |
| 07613327033342 | K910990 | 000 |
| 07613327033359 | K910990 | 000 |
| 07613327033366 | K910990 | 000 |
| 07613327033373 | K910990 | 000 |
| 07613327033380 | K910990 | 000 |
| 07613327031393 | K910990 | 000 |