The following data is part of a premarket notification filed by Arthropedics, Inc. with the FDA for Retrograde Knife, Disposable #tm-1613.
| Device ID | K873711 |
| 510k Number | K873711 |
| Device Name: | RETROGRADE KNIFE, DISPOSABLE #TM-1613 |
| Classification | Knife, Orthopedic |
| Applicant | ARTHROPEDICS, INC. 111 LESTER ST. Wallington, NJ 07057 |
| Contact | Jerry Procopio |
| Correspondent | Jerry Procopio ARTHROPEDICS, INC. 111 LESTER ST. Wallington, NJ 07057 |
| Product Code | HTS |
| CFR Regulation Number | 888.4540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-09-15 |
| Decision Date | 1987-11-02 |