The following data is part of a premarket notification filed by Osteonics Corp. with the FDA for Osteonics Ecsi Hip Stem Series.
| Device ID | K900836 |
| 510k Number | K900836 |
| Device Name: | OSTEONICS ECSI HIP STEM 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 For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-02-22 |
| Decision Date | 1990-03-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327016581 | K900836 | 000 |
| 07613327016482 | K900836 | 000 |
| 07613327016499 | K900836 | 000 |
| 07613327016505 | K900836 | 000 |
| 07613327016512 | K900836 | 000 |
| 07613327016529 | K900836 | 000 |
| 07613327016536 | K900836 | 000 |
| 07613327016543 | K900836 | 000 |
| 07613327016550 | K900836 | 000 |
| 07613327016567 | K900836 | 000 |
| 07613327016574 | K900836 | 000 |
| 07613327016475 | K900836 | 000 |