The following data is part of a premarket notification filed by Stryker Spine with the FDA for Tritanium C Anterior Cervical Cage.
Device ID | K171496 |
510k Number | K171496 |
Device Name: | Tritanium C Anterior Cervical Cage |
Classification | Intervertebral Fusion Device With Bone Graft, Cervical |
Applicant | STRYKER SPINE 2 Pearl Court Allendale, NJ 07401 |
Contact | Deborah Cynamon |
Correspondent | Deborah Cynamon STRYKER SPINE 2 Pearl Court Allendale, NJ 07401 |
Product Code | ODP |
CFR Regulation Number | 888.3080 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-05-22 |
Decision Date | 2017-09-06 |
Summary: | summary |