Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K130105
Device Classification Name
Pin, Fixation, Smooth
More FDA Info for this Device
510(K) Number
K130105
Device Name
Pin, Fixation, Smooth
Applicant
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY
325 PARAMOUNT DR.
RAYNHAM, MA 02767 US
Other 510(k) Applications for this Company
Contact
JULIE VAFIDES
Other 510(k) Applications for this Contact
Regulation Number
888.3040
More FDA Info for this Regulation Number
Classification Product Code
HTY
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
01/15/2013
Decision Date
05/17/2013
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact