The following data is part of a premarket notification filed by Orthopedic Systems, Inc. with the FDA for Femur Wrench.
| Device ID | K870126 |
| 510k Number | K870126 |
| Device Name: | FEMUR WRENCH |
| Classification | Elevator, Surgical, General & Plastic Surgery |
| Applicant | ORTHOPEDIC SYSTEMS, INC. 1897 NATIONAL AVE. Hayward, CA 94545 |
| Contact | Robert R Moore |
| Correspondent | Robert R Moore ORTHOPEDIC SYSTEMS, INC. 1897 NATIONAL AVE. Hayward, CA 94545 |
| Product Code | GEG |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-01-12 |
| Decision Date | 1987-02-03 |