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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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