The following data is part of a premarket notification filed by Camber Spine with the FDA for Verta Corpectomy Cage.
Device ID | K143490 |
510k Number | K143490 |
Device Name: | VERTA Corpectomy Cage |
Classification | Spinal Vertebral Body Replacement Device |
Applicant | CAMBER SPINE 418 E. Lancaster Ave. Wayne, PA 19087 |
Contact | Daniel A. Pontecorvo |
Correspondent | Daniel A. Pontecorvo CAMBER SPINE 418 E. Lancaster Ave. Wayne, PA 19087 |
Product Code | MQP |
CFR Regulation Number | 888.3060 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-12-08 |
Decision Date | 2015-01-26 |
Summary: | summary |