Device Classification Name |
Fastener, Fixation, Nondegradable, Soft Tissue
|
510(k) Number |
K122123 |
Device Name |
6-8MM X 30 MM INTRAFIX PEEK TAPERED SCREW 7-9MM X 30MM INTRAFIX PEEK TAPERED SCREW 8-10MM X 30 MM INTRAFIX PEEK TAPERED |
Applicant |
DEPUY MITEK INC., A JOHNSON AND JOHNSON COMPANY |
325 Paramount Drive |
Raynham,
MA
02767
|
|
Applicant Contact |
JULIE VAFIDES |
Correspondent |
DEPUY MITEK INC., A JOHNSON AND JOHNSON COMPANY |
325 Paramount Drive |
Raynham,
MA
02767
|
|
Correspondent Contact |
JULIE VAFIDES |
Regulation Number | 888.3040
|
Classification Product Code |
|
Date Received | 07/18/2012 |
Decision Date | 10/02/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|