Device Classification Name |
thoracolumbosacral pedicle screw system
|
510(k) Number |
K222614 |
Device Name |
Zavation Spinal System |
Applicant |
Zavation Medical Products, LLC |
3670 Flowood Drive |
Flowood,
MS
39232
|
|
Applicant Contact |
Frankie Cummins |
Correspondent |
Zavation Medical Products, LLC |
3670 Flowood Drive |
Flowood,
MS
39232
|
|
Correspondent Contact |
Frankie Cummins |
Regulation Number | 888.3070
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 08/30/2022 |
Decision Date | 12/05/2022 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|