The following data is part of a premarket notification filed by Osteonics Corp. with the FDA for Osteo Bos System In Stainless Steel.
| Device ID | K973204 |
| 510k Number | K973204 |
| Device Name: | OSTEO BOS SYSTEM IN STAINLESS STEEL |
| Classification | Plate, Fixation, Bone |
| Applicant | OSTEONICS CORP. 59 ROUTE 17 Allendale, NJ 07401 -1677 |
| Contact | Kate Sutton |
| Correspondent | Kate Sutton OSTEONICS CORP. 59 ROUTE 17 Allendale, NJ 07401 -1677 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-08-26 |
| Decision Date | 1997-09-25 |
| Summary: | summary |