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FDA 510(k) Application Details - K051983
Device Classification Name
Fastener, Fixation, Biodegradable, Soft Tissue
More FDA Info for this Device
510(K) Number
K051983
Device Name
Fastener, Fixation, Biodegradable, Soft Tissue
Applicant
AXYA MEDICAL, INC.
100 CUMMINGS CENTER
SUITE 444C
BEVERLY, MA 01915 US
Other 510(k) Applications for this Company
Contact
Howard Schrayer
Other 510(k) Applications for this Contact
Regulation Number
888.3030
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Classification Product Code
MAI
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/22/2005
Decision Date
08/05/2005
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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