The following data is part of a premarket notification filed by Accelerated Innovation, Llc with the FDA for Accin Bipolar Head System.
| Device ID | K080647 |
| 510k Number | K080647 |
| Device Name: | ACCIN BIPOLAR HEAD SYSTEM |
| Classification | Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented |
| Applicant | ACCELERATED INNOVATION, LLC 1033 US HIGHWAY 46 EAST SUITE A204 Clifton, NJ 07013 |
| Contact | Michael Kvitmitsky |
| Correspondent | Michael Kvitmitsky ACCELERATED INNOVATION, LLC 1033 US HIGHWAY 46 EAST SUITE A204 Clifton, NJ 07013 |
| Product Code | KWY |
| CFR Regulation Number | 888.3390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-03-07 |
| Decision Date | 2008-07-08 |
| Summary: | summary |