Device Classification Name |
Spinal Vertebral Body Replacement Device - Cervical
|
510(k) Number |
K152568 |
FOIA Releasable 510(k) |
K152568
|
Device Name |
C-VBR |
Applicant |
CARDINAL SPINE, LLC |
12307 OLD LAGRANGE ROAD, SUITE 105 |
LOUISVILLE,
KY
40245
|
|
Applicant Contact |
NATASHA LONNON |
Correspondent |
PAXMED INTERNATIONAL, LLC |
12264 EL CAMINO REAL, SUITE 400 |
SAN DIEGO,
CA
92130
|
|
Correspondent Contact |
KEVIN A THOMAS |
Regulation Number | 888.3060
|
Classification Product Code |
|
Date Received | 09/09/2015 |
Decision Date | 02/11/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|