The following data is part of a premarket notification filed by Vertebron, Inc. with the FDA for Modification To Vertebron Scp Cervical Plate System.
Device ID | K043181 |
510k Number | K043181 |
Device Name: | MODIFICATION TO 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 | 2004-11-17 |
Decision Date | 2004-12-17 |
Summary: | summary |