The following data is part of a premarket notification filed by Osteo Ag with the FDA for Osteo Cerclage Wire.
| Device ID | K914374 |
| 510k Number | K914374 |
| Device Name: | OSTEO CERCLAGE WIRE |
| Classification | Cerclage, Fixation |
| 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 | JDQ |
| CFR Regulation Number | 888.3010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-10-01 |
| Decision Date | 1991-12-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04546540066350 | K914374 | 000 |
| 04546540066343 | K914374 | 000 |
| 37613327072731 | K914374 | 000 |
| 37613327072724 | K914374 | 000 |
| 37613327072717 | K914374 | 000 |
| 37613327072700 | K914374 | 000 |
| 37613327072434 | K914374 | 000 |
| 37613327072410 | K914374 | 000 |