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FDA 510(k) Application Details - K023922
Device Classification Name
Screw, Fixation, Bone
More FDA Info for this Device
510(K) Number
K023922
Device Name
Screw, Fixation, Bone
Applicant
COAPT SYSTEMS, INC.
1152 NAVARRO ST.
SANTA ROSA, CA 95401 US
Other 510(k) Applications for this Company
Contact
SHELLEY TRIMM
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
11/25/2002
Decision Date
12/20/2002
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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