The following data is part of a premarket notification filed by Cayenne Medical, Inc. with the FDA for Quatro Link Knotless Anchor With Inserter, 2.9mm-peek Only.
| Device ID | K122314 |
| 510k Number | K122314 |
| Device Name: | QUATRO LINK KNOTLESS ANCHOR WITH INSERTER, 2.9MM-PEEK ONLY |
| 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 | 2012-08-01 |
| Decision Date | 2012-10-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00887868270222 | K122314 | 000 |
| 00887868270208 | K122314 | 000 |
| 00887868270192 | K122314 | 000 |
| 00887868270161 | K122314 | 000 |