The following data is part of a premarket notification filed by Stryker Corporation with the FDA for Acp 1 Anterior Cervical Plating System.
Device ID | K150700 |
510k Number | K150700 |
Device Name: | ACP 1 Anterior Cervical Plating System |
Classification | Appliance, Fixation, Spinal Intervertebral Body |
Applicant | STRYKER CORPORATION 2 PEARL COURT Allendale, NJ 07401 |
Contact | Tina Mornak |
Correspondent | Tina Mornak STRYKER CORPORATION 2 PEARL COURT 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 | 2015-03-18 |
Decision Date | 2015-07-15 |
Summary: | summary |