The following data is part of a premarket notification filed by Orthomet, Inc. with the FDA for Orthomet Wire For Suture, Cerclage.
| Device ID | K874919 |
| 510k Number | K874919 |
| Device Name: | ORTHOMET WIRE FOR SUTURE, CERCLAGE |
| Classification | Cerclage, Fixation |
| Applicant | ORTHOMET, INC. 6301 CECILIA CIRCLE Minneapolis, MN 55439 -2713 |
| Contact | Al Lippincott |
| Correspondent | Al Lippincott ORTHOMET, INC. 6301 CECILIA CIRCLE Minneapolis, MN 55439 -2713 |
| Product Code | JDQ |
| CFR Regulation Number | 888.3010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-12-03 |
| Decision Date | 1988-01-07 |