The following data is part of a premarket notification filed by Accelerated Innovation, Llc with the FDA for Accin Hip System.
Device ID | K073068 |
510k Number | K073068 |
Device Name: | ACCIN HIP SYSTEM |
Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
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 | LPH |
CFR Regulation Number | 888.3358 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-10-30 |
Decision Date | 2008-01-10 |
Summary: | summary |