The following data is part of a premarket notification filed by Osteonics Corp. with the FDA for Osteo Compression Condyle Screw System.
| Device ID | K971321 |
| 510k Number | K971321 |
| Device Name: | OSTEO COMPRESSION CONDYLE SCREW SYSTEM |
| Classification | Plate, Fixation, Bone |
| Applicant | OSTEONICS CORP. 59 ROUTE 17 Allendale, NJ 07401 -1677 |
| Contact | Donna S Wilson |
| Correspondent | Donna S Wilson 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 | 1997-04-10 |
| Decision Date | 1997-07-09 |
| Summary: | summary |