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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Screw, Fixation, Bone
510(k) Number K012818
Device Name HELICAL COMPRESSION ANCHOR SYSTEM, CANNULATED SINGLE HELIX
Applicant
TRIAGE MEDICAL INC
3722 AVE. SAUSALITO
IRVINE,  CA  92606
Applicant Contact GREG H HOLLAND
Correspondent
TRIAGE MEDICAL INC
3722 AVE. SAUSALITO
IRVINE,  CA  92606
Correspondent Contact GREG H HOLLAND
Regulation Number888.3040
Classification Product Code
HWC  
Date Received08/22/2001
Decision Date 11/20/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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