The following data is part of a premarket notification filed by Aesculap Implant Systems, Inc. with the FDA for Univation Unicondylar Knee System.
| Device ID | K081293 |
| 510k Number | K081293 |
| Device Name: | UNIVATION UNICONDYLAR KNEE SYSTEM |
| Classification | Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer |
| Applicant | AESCULAP IMPLANT SYSTEMS, INC. 3773 CORPORATE PKWY. Center Valley, PA 18034 |
| Contact | Lisa M Boyle |
| Correspondent | Lisa M Boyle AESCULAP IMPLANT SYSTEMS, INC. 3773 CORPORATE PKWY. Center Valley, PA 18034 |
| Product Code | HRY |
| CFR Regulation Number | 888.3530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-05-07 |
| Decision Date | 2008-09-22 |
| Summary: | summary |