FDA 510(k) Applications Submitted by GAYLE HIROTA

FDA 510(k) Number Submission Date Device Name Applicant
K080229 01/30/2008 5.5 MM SUTURE LOCK BONE SCREW ANCHOR KFX MEDICAL
K040250 02/02/2004 BONE-LOK HP WASHER TRIAGE MEDICAL INC
K120841 03/20/2012 APPIANFX SUTURE ANCHOR (6MM) (5MM) APPIANFX TISSUE ANCHOR KFX MEDICAL
K101175 04/27/2010 KFX APPIANFX PEEK FEMORAL IMPLANT WITH INSERTER KFX MEDICAL
K081598 06/06/2008 SUTURE LOCK NAIL BONE ANCHOR WITH WHITE (KFX-W-200) & BLUE (KFX-B-200) FIBERFORCE SUTURE KFX MEDICAL
K051949 07/15/2005 4.5 MM LS FACET COMPRESSION DEVICE WITH POLYMER WASHER, MODEL LSPW-45-3040 TRIAGE MEDICAL, INC.
K052043 07/28/2005 3.8MM CS FACET COMPRESSION DEVICE TRIAGE MEDICAL, INC.
K062391 08/16/2006 DISPOSABLE POSTERIOR LUMBAR STABILIZATION PROCEDURE KIT, MODELS 9045-01 AND 9045-02; COMPRESSION TOOL, MODEL 6113-00 TRIAGE MEDICAL, INC.
K042244 08/19/2004 BONE-LOK MVP CORTICAL-CANCELLOUS COMPRESSION DEVICE TRIAGE MEDICAL, INC.
K043351 12/06/2004 4.5MM BONE-LOK FACET SCREW, MODELS TFCD-45-3040S OR N; SFCD-45-3040S OR N TRIAGE MEDICAL INC
K083609 12/08/2008 KFX PEEK BONE ANCHOR WITH PRE-ATTACHED SUTURES AND INSERTER HANDLE KFX MEDICAL


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