The following data is part of a premarket notification filed by Cayenne Medical, Inc. with the FDA for Aperfix Tibial Implant With Inserter.
| Device ID | K063070 |
| 510k Number | K063070 |
| Device Name: | APERFIX TIBIAL IMPLANT WITH INSERTER |
| Classification | Screw, Fixation, Bone |
| Applicant | CAYENNE MEDICAL, INC. 11234 EL CAMINO REAL SUITE 200 San Diego, CA 92130 |
| Contact | Floyd Larson |
| Correspondent | Floyd Larson 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-10-06 |
| Decision Date | 2006-12-14 |
| Summary: | summary |