Device Classification Name |
Screw, Fixation, Bone
|
510(k) Number |
K121349 |
Device Name |
IO FIX, IO FIX PLUS, CARPALFIX, EXTREMITY MEDICAL SCREW AND WASHER |
Applicant |
EXTREMITY MEDICAL LLC |
300 INTERPACE PARKWAY |
SUITE 410 |
PARSIPPANY,
NJ
07054
|
|
Applicant Contact |
JAMY GANNOE |
Correspondent |
EXTREMITY MEDICAL LLC |
300 INTERPACE PARKWAY |
SUITE 410 |
PARSIPPANY,
NJ
07054
|
|
Correspondent Contact |
JAMY GANNOE |
Regulation Number | 888.3040
|
Classification Product Code |
|
Date Received | 05/04/2012 |
Decision Date | 07/18/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|