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FDA 510(k) Application Details - K112249
Device Classification Name
Fastener, Fixation, Biodegradable, Soft Tissue
More FDA Info for this Device
510(K) Number
K112249
Device Name
Fastener, Fixation, Biodegradable, Soft Tissue
Applicant
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY
325 PARAMOUNT DR.
RAYNHAM, MA 02767 US
Other 510(k) Applications for this Company
Contact
DEEP PAL
Other 510(k) Applications for this Contact
Regulation Number
888.3030
More FDA Info for this Regulation Number
Classification Product Code
MAI
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/05/2011
Decision Date
10/25/2011
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
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