The following data is part of a premarket notification filed by Osteo Ag with the FDA for Osteo Interlocking-compression Nail.
| Device ID | K933340 |
| 510k Number | K933340 |
| Device Name: | OSTEO INTERLOCKING-COMPRESSION NAIL |
| Classification | Rod, Fixation, Intramedullary And Accessories |
| Applicant | OSTEO AG 208 DUBLIN RD. Greenwood, SC |
| Contact | Fred C Bryson, Jr. |
| Correspondent | Fred C Bryson, Jr. OSTEO AG 208 DUBLIN RD. Greenwood, SC |
| Product Code | HSB |
| CFR Regulation Number | 888.3020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-07-08 |
| Decision Date | 1994-06-30 |