The following data is part of a premarket notification filed by Providence Medical Technology, Inc with the FDA for Cavux™ Cervical Cage.
Device ID | K161642 |
510k Number | K161642 |
Device Name: | CAVUX™ Cervical Cage |
Classification | Intervertebral Fusion Device With Bone Graft, Cervical |
Applicant | PROVIDENCE MEDICAL TECHNOLOGY, INC 1331 N. CALIFORNIA BLVD., SUITE 320 Walnut Creek, CA 94596 |
Contact | Margaret Wong |
Correspondent | Edward Liou PROVIDENCE MEDICAL TECHNOLOGY, INC 1331 N. CALIFORNIA BLVD., SUITE 320 Walnut Creek, CA 94596 |
Product Code | ODP |
CFR Regulation Number | 888.3080 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2016-06-14 |
Decision Date | 2016-10-07 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
CAVUX 87375477 5271358 Live/Registered |
Providence Medical Technology, Inc. 2017-03-17 |
CAVUX 86786467 5196437 Live/Registered |
Providence Medical Technology, Inc. 2015-10-13 |