The following data is part of a premarket notification filed by Osteonics Corp. with the FDA for Osteonics Ion Implanted Femoral Bearing Series.
| Device ID | K910988 |
| 510k Number | K910988 |
| Device Name: | OSTEONICS ION IMPLANTED FEMORAL BEARING SERIES |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
| 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 | JDI |
| CFR Regulation Number | 888.3350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-03-07 |
| Decision Date | 1991-03-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327016086 | K910988 | 000 |
| 07613327016208 | K910988 | 000 |
| 07613327016215 | K910988 | 000 |
| 07613327016222 | K910988 | 000 |
| 07613327016239 | K910988 | 000 |
| 07613327016246 | K910988 | 000 |
| 07613327016253 | K910988 | 000 |
| 07613327016260 | K910988 | 000 |
| 07613327016277 | K910988 | 000 |
| 07613327016192 | K910988 | 000 |
| 07613327016185 | K910988 | 000 |
| 07613327016178 | K910988 | 000 |
| 07613327016093 | K910988 | 000 |
| 07613327016109 | K910988 | 000 |
| 07613327016116 | K910988 | 000 |
| 07613327016123 | K910988 | 000 |
| 07613327016130 | K910988 | 000 |
| 07613327016147 | K910988 | 000 |
| 07613327016154 | K910988 | 000 |
| 07613327016161 | K910988 | 000 |
| 07613327016284 | K910988 | 000 |
| 07613327016291 | K910988 | 000 |
| 07613327016307 | K910988 | 000 |
| 07613327016673 | K910988 | 000 |
| 07613327016680 | K910988 | 000 |
| 07613327016697 | K910988 | 000 |
| 07613327016703 | K910988 | 000 |
| 07613327016710 | K910988 | 000 |
| 07613327016727 | K910988 | 000 |
| 07613327016734 | K910988 | 000 |
| 07613327016741 | K910988 | 000 |
| 07613327016666 | K910988 | 000 |
| 07613327016659 | K910988 | 000 |
| 07613327016642 | K910988 | 000 |
| 07613327016314 | K910988 | 000 |
| 07613327016321 | K910988 | 000 |
| 07613327016338 | K910988 | 000 |
| 07613327016598 | K910988 | 000 |
| 07613327016604 | K910988 | 000 |
| 07613327016611 | K910988 | 000 |
| 07613327016628 | K910988 | 000 |
| 07613327016635 | K910988 | 000 |
| 07613327016758 | K910988 | 000 |