The following data is part of a premarket notification filed by Camber Spine Technologies with the FDA for Coveris Cervical Cage System.
Device ID | K170550 |
510k Number | K170550 |
Device Name: | Coveris Cervical Cage System |
Classification | Intervertebral Fusion Device With Bone Graft, Cervical |
Applicant | Camber Spine Technologies 418 E. Lancaster Avenue Wayne, PA 19087 |
Contact | Ryan Gaffney |
Correspondent | Margeaux Rogers MCRA, LLC 1050 K Street NW Suite 1000 Washington, DC 20001 |
Product Code | ODP |
CFR Regulation Number | 888.3080 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-02-24 |
Decision Date | 2017-07-13 |
Summary: | summary |