The following data is part of a premarket notification filed by Accelerated Innovation, Llc with the FDA for Accin Pedicle Screw System.
| Device ID | K073531 |
| 510k Number | K073531 |
| Device Name: | ACCIN PEDICLE SCREW SYSTEM |
| Classification | Orthosis, Spondylolisthesis Spinal Fixation |
| 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 | MNH |
| Subsequent Product Code | KWQ |
| Subsequent Product Code | MNI |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-12-17 |
| Decision Date | 2008-02-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B41794285601 | K073531 | 000 |
| B41794265551 | K073531 | 000 |
| B41794265501 | K073531 | 000 |
| B41794265451 | K073531 | 000 |
| B41794265401 | K073531 | 000 |
| B41794265351 | K073531 | 000 |
| B41794265301 | K073531 | 000 |
| B41794255601 | K073531 | 000 |
| B41794255551 | K073531 | 000 |
| B41794255501 | K073531 | 000 |
| B41794255451 | K073531 | 000 |
| B41794255401 | K073531 | 000 |
| B41794255351 | K073531 | 000 |
| B41794265601 | K073531 | 000 |
| B41794275301 | K073531 | 000 |
| B41794285551 | K073531 | 000 |
| B41794285501 | K073531 | 000 |
| B41794285451 | K073531 | 000 |
| B41794285401 | K073531 | 000 |
| B41794285351 | K073531 | 000 |
| B41794285301 | K073531 | 000 |
| B41794275601 | K073531 | 000 |
| B41794275551 | K073531 | 000 |
| B41794275501 | K073531 | 000 |
| B41794275451 | K073531 | 000 |
| B41794275401 | K073531 | 000 |
| B41794275351 | K073531 | 000 |
| B41794255301 | K073531 | 000 |