The following data is part of a premarket notification filed by Vertebron, Inc. with the FDA for Vertebron Ssp Cervical Plating System.
| Device ID | K081567 |
| 510k Number | K081567 |
| Device Name: | VERTEBRON SSP CERVICAL PLATING SYSTEM |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | VERTEBRON, INC. 80 HATHAWAY DRIVE Stratford, CT 06615 |
| Contact | Luis Nesprido |
| Correspondent | Luis Nesprido VERTEBRON, INC. 80 HATHAWAY DRIVE Stratford, CT 06615 |
| Product Code | KWQ |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-06-04 |
| Decision Date | 2008-07-03 |
| Summary: | summary |