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510(k) K792561

Device
MINI-H-FIXATION
Applicant
GENY MEDICAL, INC.
510(k) number
K792561
Product code
JEC  
Decision
Substantially Equivalent (SESE)
Decision date
1979-12-19
Date received
1979-12-12
Regulation
888.3040
Classification name
Component, Traction, Invasive
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
66 Argonaut # 170 Aliso Viejo CA US 92656 92656

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code JEC  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K203605SteriTrakArbutus Medical, Inc.2021-04-23
K193256Anjon Bremer Halo SystemAnjon Holdings, LLC2020-03-02
K192465DigiFix Sterile KitVirak Orthopedics, LLC2019-10-10
K181192PIP FixHand Biomechanics Lab, Inc.2018-10-22
K171863Anjon Bremer Halo SystemAnjon Holdings, LLC2018-03-19
K163028Medline ReNewal Reprocessed Stryker External Fixation DevicesSurgical Instrument Service and Savings, Inc.2016-12-28
K132731DIGIFIX EXTERNAL FIXATION SYSTEMVirak Orthopedic Research, LLC2014-01-10
K102885HOFFMANN II EXTERNAL FIXATION SYSTEM LINE EXTENSION MODEL 4920-1-010, 4920-1-020, 4920-1-030, 4920-1-100, HOFFMANN II EXStryker Corp.2011-01-14
K082679LAKI HAND FIXATION SYSTEM, MODEL TFX.3X.06.XSintea Biotech, Inc.2009-04-07
K072432F3 FRACTURED FINGER FIXATOR, STERILE (MODEL: FCS 400) AND NON STERILEHand Biomechanics Lab, Inc.2008-01-09
K071476SYNTHES (USA) 2ND GENERATION PELVIC C-CLAMPSynthes (Usa)2007-08-24
K042066KLSA MARTIN HAND DISTRACTORKLS-Martin L.P.2004-08-25
K032427FEP FIXATION SYSTEM AND STYLO WRIST FIXATION SYSTEMMeridan Medical2003-10-09
K031941HOFFMANN II COMPACT BALTIMORE COUPLINGHowmedica Osteonics Corp.2003-07-24
K030519WRISTJACK SYSTEM (REMANUFACTURED), STERILE AND NON-STERILE, MODELS CFD-147-RS, CFD-247-RNSHand Biomechanics Lab, Inc.2003-06-10

Legacy Summary#

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FDA Review#

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