The following data is part of a premarket notification filed by Cayenne Medical, Inc. with the FDA for Afx™ Femoral Implant With Inserter.
| Device ID | K161033 |
| 510k Number | K161033 |
| Device Name: | AFX™ Femoral Implant With Inserter |
| 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 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 | 2016-04-13 |
| Decision Date | 2016-08-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M543CM2410AP1 | K161033 | 000 |
| M543CM2409AP1 | K161033 | 000 |