The following data is part of a premarket notification filed by Stryker Spine with the FDA for Thor Anterior Plating System.
Device ID | K073437 |
510k Number | K073437 |
Device Name: | THOR ANTERIOR PLATING SYSTEM |
Classification | Appliance, Fixation, Spinal Intervertebral Body |
Applicant | STRYKER SPINE 2 PEARL COURT Allendale, NJ 07401 |
Contact | Curtis Truesdale |
Correspondent | Curtis Truesdale STRYKER SPINE 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 | 2007-12-06 |
Decision Date | 2008-02-13 |
Summary: | summary |