The following data is part of a premarket notification filed by Accelerated Innovation, Llc with the FDA for Accin Patellofemoral System.
Device ID | K073120 |
510k Number | K073120 |
Device Name: | ACCIN PATELLOFEMORAL SYSTEM |
Classification | Prosthesis, Knee, Patello/femoral, Semi-constrained, Cemented, 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 | KRR |
CFR Regulation Number | 888.3540 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-11-05 |
Decision Date | 2008-02-29 |