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FDA 510(k) Application Details - K014243
Device Classification Name
Screw, Fixation, Bone
More FDA Info for this Device
510(K) Number
K014243
Device Name
Screw, Fixation, Bone
Applicant
TRIAGE MEDICAL INC
13700 ALTON PKWY.
SUITE 167
IRVINE, CA 92618 US
Other 510(k) Applications for this Company
Contact
BRAD CULBERT
Other 510(k) Applications for this Contact
Regulation Number
888.3040
More FDA Info for this Regulation Number
Classification Product Code
HWC
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/26/2001
Decision Date
03/26/2002
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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