The following data is part of a premarket notification filed by Osteo Ag with the FDA for Osteo Ex-fi-re.
| Device ID | K920149 |
| 510k Number | K920149 |
| Device Name: | OSTEO EX-FI-RE |
| Classification | Component, Traction, Invasive |
| Applicant | OSTEO AG 208 WILSON BRIDGE RD. Greenwood, SC 29646 |
| Contact | Bryson, Jr. |
| Correspondent | Bryson, Jr. OSTEO AG 208 WILSON BRIDGE RD. Greenwood, SC 29646 |
| Product Code | JEC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-01-10 |
| Decision Date | 1992-04-09 |