The following data is part of a premarket notification filed by Cayenne Medical, Inc with the FDA for Quattro Bolt Tenodesis Screw.
| Device ID | K143392 |
| 510k Number | K143392 |
| Device Name: | Quattro Bolt Tenodesis Screw |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | CAYENNE MEDICAL, INC 16597 N. 92ND ST Scottsdale, AZ 85260 |
| Contact | Shima Hashemian |
| Correspondent | Shima Hashemian CAYENNE MEDICAL, INC 16597 N. 92ND ST 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 | 2014-11-26 |
| Decision Date | 2015-01-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00887868270420 | K143392 | 000 |
| 00887868270413 | K143392 | 000 |
| 00887868270406 | K143392 | 000 |
| 00887868270390 | K143392 | 000 |
| 00887868270383 | K143392 | 000 |