The following data is part of a premarket notification filed by Stryker Corporation with the FDA for Aviator Anterior Cervical Plate (acp) System.
Device ID | K142237 |
510k Number | K142237 |
Device Name: | Aviator Anterior Cervical Plate (ACP) System |
Classification | Appliance, Fixation, Spinal Intervertebral Body |
Applicant | Stryker Corporation 2 Pearl Court Stryker Spine Division Allendale, NJ 07401 |
Contact | Soraya King |
Correspondent | Soraya King Stryker Corporation 2 Pearl Court Stryker Spine Division Allendale, NJ 07401 |
Product Code | KWQ |
CFR Regulation Number | 888.3060 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-08-13 |
Decision Date | 2015-01-26 |
Summary: | summary |