The following data is part of a premarket notification filed by Stryker Spine with the FDA for Tritanium Pl Cage.
Device ID | K181014 |
510k Number | K181014 |
Device Name: | Tritanium PL Cage |
Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
Applicant | Stryker Spine 2 Pearl Court Allendale, NJ 07401 |
Contact | Travis Catania |
Correspondent | Travis Catania Stryker Spine 2 Pearl Court Allendale, NJ 07401 |
Product Code | MAX |
CFR Regulation Number | 888.3080 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2018-04-17 |
Decision Date | 2018-07-18 |
Summary: | summary |