Device Classification Name |
Intervertebral Fusion Device With Integrated Fixation, Lumbar
|
510(k) Number |
K151312 |
Device Name |
VerteLP Interbody Fusion Device |
Applicant |
VGI, LLC |
150 253rd Ave |
St. Petersburg,
FL
33708
|
|
Applicant Contact |
Tov Vestgaarten |
Correspondent |
Silver Pine Consulting, LLC. |
11821 Bramble Cove Drive |
Ft. Myers,
FL
33905
|
|
Correspondent Contact |
Rich Jansen |
Regulation Number | 888.3080 |
Classification Product Code |
|
Date Received | 05/18/2015 |
Decision Date | 01/13/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
Recalls |
CDRH Recalls
|
|
|