Device Classification Name |
orthosis, spondylolisthesis spinal fixation
|
510(k) Number |
K153404 |
Device Name |
Zavation Spinal System |
Applicant |
ZAVATION, LLC |
400 LIBERTY PARK DR |
FLOWOOD,
MS
39232
|
|
Applicant Contact |
Lawrence Walker |
Correspondent |
ZAVATION, LLC |
400 LIBERTY PARK DR |
FLOWOOD,
MS
39232
|
|
Correspondent Contact |
Lawrence Walker |
Regulation Number | 888.3070
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 11/24/2015 |
Decision Date | 04/21/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|