The following data is part of a premarket notification filed by Vertebron, Inc. with the FDA for Vertebron Scp Cervical Plate System.
| Device ID | K062110 |
| 510k Number | K062110 |
| Device Name: | VERTEBRON SCP CERVICAL PLATE SYSTEM |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | VERTEBRON, INC. 400 LONG BEACH BLVD. Stratford, CT 06615 |
| Contact | Luis Nesprido |
| Correspondent | Luis Nesprido VERTEBRON, INC. 400 LONG BEACH BLVD. 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 | 2006-07-24 |
| Decision Date | 2006-08-16 |
| Summary: | summary |