The following data is part of a premarket notification filed by Orthopedic Systems, Inc. with the FDA for Bone Nail W/washer & An Arthroscopic Insertion Sys.
| Device ID | K875130 |
| 510k Number | K875130 |
| Device Name: | BONE NAIL W/WASHER & AN ARTHROSCOPIC INSERTION SYS |
| Classification | Arthroscope |
| 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 | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-12-15 |
| Decision Date | 1989-01-30 |