Device Classification Name |
plate, fixation, bone
|
510(k) Number |
K100240 |
Device Name |
ORTHOPEDIATRICS PEDILOC TIBIA 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 | 01/27/2010 |
Decision Date | 05/17/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|