Device Classification Name |
Fastener, Fixation, Nondegradable, Soft Tissue
|
510(k) Number |
K130217 |
Device Name |
ORTHOPEDIATRICS ACL RECONSTRUCTIVE SYSTEM |
Applicant |
ORTHOPEDIATRICS, CORP. |
2850 FRONTIER DRIVE |
WARSAW,
IN
46582
|
|
Applicant Contact |
MARK FOX |
Correspondent |
ORTHOPEDIATRICS, CORP. |
2850 FRONTIER DRIVE |
WARSAW,
IN
46582
|
|
Correspondent Contact |
MARK FOX |
Regulation Number | 888.3040
|
Classification Product Code |
|
Date Received | 01/29/2013 |
Decision Date | 06/20/2013 |
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
|
|
|