The following data is part of a premarket notification filed by Stryker Corp. with the FDA for Stryker Spine Nulock Anterior Cervical Plating System.
Device ID | K083562 |
510k Number | K083562 |
Device Name: | STRYKER SPINE NULOCK ANTERIOR CERVICAL PLATING SYSTEM |
Classification | Appliance, Fixation, Spinal Intervertebral Body |
Applicant | STRYKER CORP. 2 PEARL COURT Allendale, NJ 07401 |
Contact | Kimberly Lane |
Correspondent | Kimberly Lane STRYKER CORP. 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 | 2008-12-02 |
Decision Date | 2009-03-25 |
Summary: | summary |