The following data is part of a premarket notification filed by Orthopedic Systems, Inc. with the FDA for Isometric Acl Drill Guide.
| Device ID | K853762 |
| 510k Number | K853762 |
| Device Name: | ISOMETRIC ACL DRILL GUIDE |
| Classification | Motor, Surgical Instrument, Ac-powered |
| 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 | GEY |
| CFR Regulation Number | 878.4820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-09-09 |
| Decision Date | 1985-10-07 |