The following data is part of a premarket notification filed by Osteonics Corp. with the FDA for Osteonics Omnifit Ad-ha Hip Stem Series.
| Device ID | K941366 |
| 510k Number | K941366 |
| Device Name: | OSTEONICS OMNIFIT AD-HA HIP STEM SERIES |
| Classification | Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate |
| Applicant | OSTEONICS CORP. 59 ROUTE 17 Allendale, NJ 07401 -1677 |
| Contact | Robert A Koch |
| Correspondent | Robert A Koch OSTEONICS CORP. 59 ROUTE 17 Allendale, NJ 07401 -1677 |
| Product Code | MEH |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-03-21 |
| Decision Date | 1995-06-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327020656 | K941366 | 000 |
| 07613327020564 | K941366 | 000 |
| 07613327020571 | K941366 | 000 |
| 07613327020588 | K941366 | 000 |
| 07613327020595 | K941366 | 000 |
| 07613327020601 | K941366 | 000 |
| 07613327020618 | K941366 | 000 |
| 07613327020625 | K941366 | 000 |
| 07613327020632 | K941366 | 000 |
| 07613327020649 | K941366 | 000 |
| 07613327020557 | K941366 | 000 |