The following data is part of a premarket notification filed by Arthrex, Inc. with the FDA for Acl Tightrope Double Bundle.
| Device ID | K101837 |
| 510k Number | K101837 |
| Device Name: | ACL TIGHTROPE DOUBLE BUNDLE |
| Classification | Pin, Fixation, Smooth |
| Applicant | ARTHREX, INC. 1370 CREEKSIDE BLVD. Naples, FL 34108 -1945 |
| Contact | Geena Augustine |
| Correspondent | Geena Augustine ARTHREX, INC. 1370 CREEKSIDE BLVD. Naples, FL 34108 -1945 |
| Product Code | HTY |
| Subsequent Product Code | GAP |
| Subsequent Product Code | GAT |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-07-01 |
| Decision Date | 2010-12-28 |