The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Arthroscopic Surgical Instruments - Interference Screw Systems.
| Device ID | K122596 |
| 510k Number | K122596 |
| Device Name: | ARTHROSCOPIC SURGICAL INSTRUMENTS - INTERFERENCE SCREW SYSTEMS |
| Classification | Screw, Fixation, Bone |
| Applicant | SMITH & NEPHEW, INC. 150 MINUTEMAN RD. Andover, MA 01810 |
| Contact | Sean Reynolds |
| Correspondent | Sean Reynolds SMITH & NEPHEW, INC. 150 MINUTEMAN RD. Andover, MA 01810 |
| Product Code | HWC |
| Subsequent Product Code | MAI |
| Subsequent Product Code | MBI |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-08-24 |
| Decision Date | 2012-11-20 |
| Summary: | summary |