The following data is part of a premarket notification filed by Cayenne Medical, Inc. with the FDA for Aperfix Femoral Implant With Inserter, 9,10,11 Mm X 35mm And X 29mm.
| Device ID | K083612 |
| 510k Number | K083612 |
| Device Name: | APERFIX FEMORAL IMPLANT WITH INSERTER, 9,10,11 MM X 35MM AND X 29MM |
| Classification | Screw, Fixation, Bone |
| Applicant | CAYENNE MEDICAL, INC. 16597 N. 92ND STREET SUITE 101 Scottsdale, AZ 85260 |
| Contact | Kereshmeh Shahriari |
| Correspondent | Kereshmeh Shahriari CAYENNE MEDICAL, INC. 16597 N. 92ND STREET SUITE 101 Scottsdale, AZ 85260 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-12-05 |
| Decision Date | 2009-03-04 |
| Summary: | summary |