The following data is part of a premarket notification filed by Accel Spine with the FDA for Van Gogh Anterior Cervical Plate System.
Device ID | K121078 |
510k Number | K121078 |
Device Name: | VAN GOGH ANTERIOR CERVICAL PLATE SYSTEM |
Classification | Appliance, Fixation, Spinal Intervertebral Body |
Applicant | ACCEL SPINE 14850 Quorum Dr Ste 220 Dallas, TX 75254 |
Contact | Daniel Chon |
Correspondent | Daniel Chon ACCEL SPINE 14850 Quorum Dr Ste 220 Dallas, TX 75254 |
Product Code | KWQ |
CFR Regulation Number | 888.3060 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2012-04-09 |
Decision Date | 2012-09-13 |
Summary: | summary |