The following data is part of a premarket notification filed by Cayenne Medical, Inc. with the FDA for Modification To Aperfix Femoral Implant With Inserter.
| Device ID | K073054 |
| 510k Number | K073054 |
| Device Name: | MODIFICATION TO APERFIX FEMORAL IMPLANT WITH INSERTER |
| Classification | Screw, Fixation, Bone |
| Applicant | CAYENNE MEDICAL, INC. 11234 EL CAMINO REAL SUITE 200 San Diego, CA 92130 |
| Contact | David J Collette |
| Correspondent | David J Collette CAYENNE MEDICAL, INC. 11234 EL CAMINO REAL SUITE 200 San Diego, CA 92130 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-10-30 |
| Decision Date | 2007-11-27 |
| Summary: | summary |