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FDA 510(k) Application Details - K153186
Device Classification Name
Fastener, Fixation, Nondegradable, Soft Tissue
More FDA Info for this Device
510(K) Number
K153186
Device Name
Fastener, Fixation, Nondegradable, Soft Tissue
Applicant
ARTHROCARE CORP.
15285 ALTON PARKWAY, NO. 200
IRVINE, CA 92618 US
Other 510(k) Applications for this Company
Contact
Katherine Marcaccio
Other 510(k) Applications for this Contact
Regulation Number
888.3040
More FDA Info for this Regulation Number
Classification Product Code
MBI
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
11/03/2015
Decision Date
01/28/2016
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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