The following data is part of a premarket notification filed by Arthrex, Inc. with the FDA for Arthrex Fibertape Cerclage.
| Device ID | K170206 |
| 510k Number | K170206 |
| Device Name: | Arthrex FiberTape Cerclage |
| Classification | Cerclage, Fixation |
| Applicant | ARTHREX, INC. 1370 CREEKSIDE BOULEVARD Naples, FL 34108 -1945 |
| Contact | Ivette Galmez |
| Correspondent | Ivette Galmez ARTHREX, INC. 1370 CREEKSIDE BOULEVARD Naples, FL 34108 -1945 |
| Product Code | JDQ |
| CFR Regulation Number | 888.3010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-01-24 |
| Decision Date | 2017-11-15 |
| Summary: | summary |