The following data is part of a premarket notification filed by Osteonics Corp. with the FDA for Osteo I-c Humeral Nail System.
| Device ID | K981309 |
| 510k Number | K981309 |
| Device Name: | OSTEO I-C HUMERAL NAIL SYSTEM |
| Classification | Rod, Fixation, Intramedullary And Accessories |
| Applicant | OSTEONICS CORP. 59 ROUTE 17 Allendale, NJ 07401 -1677 |
| Contact | Marybeth Naughton |
| Correspondent | Marybeth Naughton OSTEONICS CORP. 59 ROUTE 17 Allendale, NJ 07401 -1677 |
| Product Code | HSB |
| CFR Regulation Number | 888.3020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-04-10 |
| Decision Date | 1998-06-22 |
| Summary: | summary |