Device Classification Name |
Thoracolumbosacral Pedicle Screw System
|
510(k) Number |
K150600 |
Device Name |
Response 5.5/6.0 Spine System |
Applicant |
ORTHOPEDIATRICS CORP. |
2850 FRONTIER DRIVE |
WARSAW,
IL
46582
|
|
Applicant Contact |
MARK FOX |
Correspondent |
ORTHOPEDIATRICS CORP. |
2850 Frontier Drive |
Warsaw,
IN
46582
|
|
Correspondent Contact |
Mark Fox |
Regulation Number | 888.3070
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 03/10/2015 |
Decision Date | 05/22/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|