The following data is part of a premarket notification filed by Orthomet, Inc. with the FDA for Orthomet Bone Screws.
| Device ID | K875050 |
| 510k Number | K875050 |
| Device Name: | ORTHOMET BONE SCREWS |
| Classification | Screw, Fixation, Bone |
| 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 | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-12-08 |
| Decision Date | 1988-01-07 |