The following data is part of a premarket notification filed by Cayenne Medical, Inc. with the FDA for Biowick X Implant With Driver.
| Device ID | K172186 |
| 510k Number | K172186 |
| Device Name: | BioWick X Implant With Driver |
| 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 | 2017-07-20 |
| Decision Date | 2017-10-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00887868269813 | K172186 | 000 |
| 00887868269790 | K172186 | 000 |
| M543CM6265 | K172186 | 000 |
| M543CM6255 | K172186 | 000 |