The following data is part of a premarket notification filed by Cayenne Medical with the FDA for Afx Femoral Implant With Inserter.
| Device ID | K192428 |
| 510k Number | K192428 |
| Device Name: | AFX Femoral Implant With Inserter |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | Cayenne Medical 16597 N 92nd Street Scottsdale, AZ 85260 |
| Contact | Shima Hashemian |
| Correspondent | Shima Hashemian Cayenne Medical 16597 N 92nd Street Scottsdale, AZ 85260 |
| Product Code | MBI |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-09-05 |
| Decision Date | 2019-10-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00887868380372 | K192428 | 000 |
| 00887868380365 | K192428 | 000 |