The following data is part of a premarket notification filed by Cayenne Medical, Inc. with the FDA for Labralink Suture Anchor With Inserter, 2.9mm Per-loaded With One (1) And (2) #2 Uhmwpe Suture.
| Device ID | K112960 |
| 510k Number | K112960 |
| Device Name: | LABRALINK SUTURE ANCHOR WITH INSERTER, 2.9MM PER-LOADED WITH ONE (1) AND (2) #2 UHMWPE SUTURE |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | CAYENNE MEDICAL, INC. 16597 N. 92ND STREET SUITE 101 Scottsdale, AZ 85260 |
| Contact | Kereshmeh Shahriari |
| Correspondent | Kereshmeh Shahriari CAYENNE MEDICAL, INC. 16597 N. 92ND STREET SUITE 101 Scottsdale, AZ 85260 |
| Product Code | MBI |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-10-05 |
| Decision Date | 2012-01-09 |
| Summary: | summary |