The following data is part of a premarket notification filed by Arthrex, Inc. with the FDA for Tightrope Syndesmosis Repair Kit, Titanium, Model Ar-8920ds; Stainless Steel. Model Ar-8921ds.
| Device ID | K043248 |
| 510k Number | K043248 |
| Device Name: | TIGHTROPE SYNDESMOSIS REPAIR KIT, TITANIUM, MODEL AR-8920DS; STAINLESS STEEL. MODEL AR-8921DS |
| 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 | 2004-11-23 |
| Decision Date | 2005-02-16 |
| Summary: | summary |