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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Facet Screw Spinal Device
510(k) Number K043351
Device Name 4.5MM BONE-LOK FACET SCREW, MODELS TFCD-45-3040S OR N; SFCD-45-3040S OR N
Applicant
Triage Medical, Inc.
13700 Alton Pkwy.
Suite 160
Irvine,  CA  92618
Applicant Contact GAYLE HIROTA
Correspondent
Triage Medical, Inc.
13700 Alton Pkwy.
Suite 160
Irvine,  CA  92618
Correspondent Contact GAYLE HIROTA
Classification Product Code
MRW  
Date Received12/06/2004
Decision Date 02/18/2005
Decision Substantially Equivalent (SESE)
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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