The following data is part of a premarket notification filed by Cayenne Medical, Inc with the FDA for Surelock W Suture Anchor.
| Device ID | K151068 |
| 510k Number | K151068 |
| Device Name: | SureLock W Suture Anchor |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | CAYENNE MEDICAL, INC 16597 N 92ND STREET 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 | 2015-04-21 |
| Decision Date | 2015-07-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00887868269769 | K151068 | 000 |
| M543CM6127 | K151068 | 000 |