The following data is part of a premarket notification filed by Choice Spine, Lp with the FDA for Choice Spine Anterior Cervical Plate (acp) System.
Device ID | K091926 |
510k Number | K091926 |
Device Name: | CHOICE SPINE ANTERIOR CERVICAL PLATE (ACP) SYSTEM |
Classification | Appliance, Fixation, Spinal Intervertebral Body |
Applicant | CHOICE SPINE, LP 8202 SHERMAN ROAD Chesterland, OH 44026 -2141 |
Contact | Karen Warden |
Correspondent | Karen Warden CHOICE SPINE, LP 8202 SHERMAN ROAD Chesterland, OH 44026 -2141 |
Product Code | KWQ |
CFR Regulation Number | 888.3060 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2009-06-30 |
Decision Date | 2009-12-22 |
Summary: | summary |