The following data is part of a premarket notification filed by Osteonics Corp. with the FDA for Osteonics 22mm, +10 Neck Bearing Heads.
| Device ID | K933359 |
| 510k Number | K933359 |
| Device Name: | OSTEONICS 22MM, +10 NECK BEARING HEADS |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Uncemented |
| 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 | LWJ |
| CFR Regulation Number | 888.3360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-07-09 |
| Decision Date | 1994-03-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327016765 | K933359 | 000 |