The following data is part of a premarket notification filed by Arthrex, Inc. with the FDA for Arthrex Suture Anchor Screw System.
| Device ID | K934327 |
| 510k Number | K934327 |
| Device Name: | ARTHREX SUTURE ANCHOR SCREW SYSTEM |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | ARTHREX, INC. 3050 NORTH HORSESHOE DR. SUITE 200 Naples, FL 33942 |
| Contact | Leonard E Baltz, Jr. |
| Correspondent | Leonard E Baltz, Jr. ARTHREX, INC. 3050 NORTH HORSESHOE DR. SUITE 200 Naples, FL 33942 |
| Product Code | MBI |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-09-03 |
| Decision Date | 1995-09-15 |