The following data is part of a premarket notification filed by Accelerated Innovation, Llc with the FDA for Accin Total Knee System.
| Device ID | K081127 |
| 510k Number | K081127 |
| Device Name: | ACCIN TOTAL KNEE SYSTEM |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | ACCELERATED INNOVATION, LLC 1033 US HIGHWAY 46 EAST SUITE A204 Clifton, NJ 07013 |
| Contact | Michael Kvitnitsky |
| Correspondent | Michael Kvitnitsky ACCELERATED INNOVATION, LLC 1033 US HIGHWAY 46 EAST SUITE A204 Clifton, NJ 07013 |
| Product Code | JWH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-04-21 |
| Decision Date | 2008-10-17 |
| Summary: | summary |