The following data is part of a premarket notification filed by Arthrex, Inc. with the FDA for Tightrope Acromioclavicular (ac) Device, Titanium, Stainless Steel , Models Ar-2257, Ar-tbd.
| Device ID | K052776 |
| 510k Number | K052776 |
| Device Name: | TIGHTROPE ACROMIOCLAVICULAR (AC) DEVICE, TITANIUM, STAINLESS STEEL , MODELS AR-2257, AR-TBD |
| Classification | Washer, Bolt Nut |
| Applicant | ARTHREX, INC. 1370 CREEKSIDE BLVD. Naples, FL 34108 -1945 |
| Contact | Sally Foust |
| Correspondent | Sally Foust ARTHREX, INC. 1370 CREEKSIDE BLVD. Naples, FL 34108 -1945 |
| Product Code | HTN |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-10-03 |
| Decision Date | 2005-12-13 |
| Summary: | summary |