The following data is part of a premarket notification filed by Stryker Spine with the FDA for Vlift-s Vertebral Body Replacement System.
Device ID | K183071 |
510k Number | K183071 |
Device Name: | VLIFT-s Vertebral Body Replacement System |
Classification | Spinal Vertebral Body Replacement Device - Cervical |
Applicant | Stryker Spine 2 Pearl Court Allendale, NJ 07401 |
Contact | Renee Norby |
Correspondent | Renee Norby Stryker Spine 2 Pearl Court Allendale, NJ 07401 |
Product Code | PLR |
CFR Regulation Number | 888.3060 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2018-11-05 |
Decision Date | 2019-01-10 |
Summary: | summary |