Device Classification Name |
Plate, Fixation, Bone
|
510(k) Number |
K083286 |
Device Name |
ORTHOPEDIATRICS PEDILOC LOCKING PLATE SYSTEM |
Applicant |
ORTHOPEDIATRICS, CORP. |
210 N. BUFFALO ST. |
WARSAW,
IN
46580
|
|
Applicant Contact |
GARY BARNETT |
Correspondent |
ORTHOPEDIATRICS, CORP. |
210 N. BUFFALO ST. |
WARSAW,
IN
46580
|
|
Correspondent Contact |
GARY BARNETT |
Regulation Number | 888.3030
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 11/05/2008 |
Decision Date | 01/30/2009 |
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
|
|
|