The following data is part of a premarket notification filed by Cayenne Medical, Inc. with the FDA for Surelock All-suture Anchor With Inserter, 1.4mm, Surelock All-suture Anchor With Inserter, 2.2mm.
| Device ID | K132867 |
| 510k Number | K132867 |
| Device Name: | SURELOCK ALL-SUTURE ANCHOR WITH INSERTER, 1.4MM, SURELOCK ALL-SUTURE ANCHOR WITH INSERTER, 2.2MM |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | CAYENNE MEDICAL, INC. 16597 N. 92ND STREET SUITE 101 Scottsdale, AZ 85260 |
| Contact | Shima Hashemian |
| Correspondent | Shima Hashemian 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 | 2013-09-13 |
| Decision Date | 2013-12-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00887868270529 | K132867 | 000 |
| 00887868270482 | K132867 | 000 |