The following data is part of a premarket notification filed by Vertebron, Inc. with the FDA for Vertebron Scp Cervical Plate System.
| Device ID | K040003 |
| 510k Number | K040003 |
| Device Name: | VERTEBRON SCP CERVICAL PLATE SYSTEM |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | VERTEBRON, INC. 136 ALBERT AVENUE Stratford, CT 06614 |
| Contact | Bruce Khalili |
| Correspondent | Bruce Khalili VERTEBRON, INC. 136 ALBERT AVENUE Stratford, CT 06614 |
| Product Code | KWQ |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-01-02 |
| Decision Date | 2004-03-26 |
| Summary: | summary |