The following data is part of a premarket notification filed by Arthrex, Inc. with the FDA for Arthrex Interference Screw-rounded Head Screws, Full Threaded Screws, Sheathed Cannulated Interference Screws.
| Device ID | K052607 |
| 510k Number | K052607 |
| Device Name: | ARTHREX INTERFERENCE SCREW-ROUNDED HEAD SCREWS, FULL THREADED SCREWS, SHEATHED CANNULATED INTERFERENCE SCREWS |
| Classification | Screw, Fixation, Bone |
| Applicant | ARTHREX, INC. 1370 CREEKSIDE BLVD. Naples, FL 34108 -1945 |
| Contact | Ann Waterhouse |
| Correspondent | Ann Waterhouse ARTHREX, INC. 1370 CREEKSIDE BLVD. Naples, FL 34108 -1945 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-09-22 |
| Decision Date | 2005-11-07 |