JEC

Product Code: JEC


Products Classified as JEC

4538Component, Traction, InvasiveSmooth Or Threaded Metallic Bone Fixation Fastener.

Total Product Life Cycle (TPLC) Devices

4538Component, Traction, InvasiveSmooth Or Threaded Metallic Bone Fixation Fastener.

FDA Consensus Standards

Component, Traction, Invasive [34059]21 CFR §888.3040 🔎
Component, Traction, Invasive [34070]21 CFR §888.3040 🔎
Component, Traction, Invasive [37410]21 CFR §888.3040 🔎
Component, Traction, Invasive [37411]21 CFR §888.3040 🔎

Pre-market Notifications for JEC

K203605SteriTrakArbutus Medical Inc.
K193256Anjon Bremer Halo SystemAnjon Holdings LLC
K192465DigiFix Sterile KitVirak Orthopedics, LLC
K181192PIP FixHand Biomechanics Lab, Inc.
K171863Anjon Bremer Halo SystemAnjon Holdings, LLC
K163028Medline ReNewal Reprocessed Stryker External Fixation DevicesSURGICAL INSTRUMENT SERVICE AND SAVINGS INC
K132731DIGIFIX EXTERNAL FIXATION SYSTEMVIRAK ORTHOPEDIC RESEARCH, LLC
K102885HOFFMANN II EXTERNAL FIXATION SYSTEM LINE EXTENSION MODEL 4920-1-010, 4920-1-020, 4920-1-030, 4920-1-100, HOFFMANN II EXSTRYKER CORP.
K082679LAKI HAND FIXATION SYSTEM, MODEL TFX.3X.06.XSINTEA BIOTECH, INC.
K072432F3 FRACTURED FINGER FIXATOR, STERILE (MODEL: FCS 400) AND NON STERILEHAND BIOMECHANICS LAB, INC.
K071476SYNTHES (USA) 2ND GENERATION PELVIC C-CLAMPSYNTHES (USA)
K042066KLSA MARTIN HAND DISTRACTORKLS-MARTIN L.P.
K032427FEP FIXATION SYSTEM AND STYLO WRIST FIXATION SYSTEMMERIDAN MEDICAL
K031941HOFFMANN II COMPACT BALTIMORE COUPLINGHOWMEDICA OSTEONICS CORP.
K030519WRISTJACK SYSTEM (REMANUFACTURED), STERILE AND NON-STERILE, MODELS CFD-147-RS, CFD-247-RNSHAND BIOMECHANICS LAB, INC.

Global Unique Device Identification Database

00810592030534Component, Traction, Invasive
00810592030442Component, Traction, Invasive
00810592030435Component, Traction, Invasive
00810592030428Component, Traction, Invasive
00810592030411Component, Traction, Invasive
00810592030404Component, Traction, Invasive
00810592030398Component, Traction, Invasive
00810592030381Component, Traction, Invasive
00810592030374Component, Traction, Invasive
00810592030367Component, Traction, Invasive
00810592030350Component, Traction, Invasive
00810592030343Component, Traction, Invasive
00810592030329Component, Traction, Invasive
00810592030312Component, Traction, Invasive
00810592030305Component, Traction, Invasive

Maude Adverse Events

3-D HALO CROWN SYSTEMDEPUY SPINE INC2020-01-10
STABLELOC EXTERNAL FIXATOR KITACUMED LLC2019-12-18
PIN TO ROD COUPLING HOFFMANN II COMPACT 5/3-4MMSTRYKER GMBH2019-09-30
PIP FIXHAND BIOMECHANICS LAB, INC.2019-05-14
UNKNOWN BREMER DEVICESDEPUY SPINE INC2018-06-26
TURNKEY FCSHAND BIOMECHANICS LAB, INC.2018-04-17
TURNKEY FCSHAND BIOMECHANICS LAB, INC2017-12-13
TRACTION,COMPONENT,INVASIVEOBERDORF : SYNTHES PRODUKTIONS GMBH2017-12-05
BREMER 3D HALO CROWNDEPUY SYNTHES SPINE2017-11-07
3-D HALO CROWN SYSTEMDEPUY SYNTHES SPINE2017-06-14
TRACTION, COMPONENT, INVASIVESYNTHES USA2017-04-26
TRACTION, COMPONENT, INVASIVESYNTHES USA2017-04-20
TRACTION, COMPONENT, INVASIVESYNTHES USA2017-04-20
TRACTION, COMPONENT, INVASIVESYNTHES USA2017-04-20
TRACTION, COMPONENT, INVASIVESYNTHES USA2017-04-20
UPPER SIDE ARM FOR PELVIC C-CLAMP IISYNTHES BETTLACH2017-03-17
OUTER RAIL FOR PELVIC C-CLAMP IISYNTHES BETTLACH2017-03-13
OUTER RAIL FOR PELVIC C-CLAMP IISYNTHES BETTLACH2017-03-13
ROD TO ROD COUPLING HOFFMANN II COMPACT 5/5MMSTRYKER GMBH2016-09-14
SMALL HALO CROWNDEPUY SYNTHES SPINE2016-07-19
UNKNOWN HALO FIXATION PINDEPUY SYNTHES SPINE2016-07-18
3-D HALO CROWN SYSTEM (TYVEK)DEPUY SYNTHES SPINE2016-06-27
CROWN SET SMDEPUY SYNTHES SPINE2016-06-07
STABLELOC EXTERNAL FIXATOR KITACUMED LLC2016-05-19
STANDARD TPLO JIG FOR USE W/24MM/27MM/30MM SAW GUIDESSYNTHES MONUMENT2016-04-20
UPPER SIDE ARM FOR PELVIC C-CLAMP IISYNTHES BETTLACH2016-03-16
3-HOLE WIRE CLAMP SLIDER UNITORTHOFIX SRL2015-12-02
TRACTION, COMPONENT, INVASIVESYNTHES USA2014-06-27
TRACTION, COMPONENT, INVASIVESYNTHES USA2014-06-27
WIRE TENSIONERORTHOFIX SRL2014-06-13
REDUCTION UNITORTHOFIX SRL2014-04-17
3D CROWN MAYFIELD SLIDER ASSYDEPUY SYNTHES SPINE2014-02-25
SKULL PIN 2000 PKG-5-STRLDEPUY SYNTHES SPINE2014-01-15
CONNECTING ROD HOFFMANN II ? 8 X 150MMSTRYKER TRAUMA SELZACH2013-12-03
FFS IMPLANTSORTHOFIX SRL2013-11-20
3-D HALO CROWN SYSTEMDEPUY SYNTHES SPINE2013-10-02
PIN TO ROD COUPLING HOFFMANN II COMPACT 5/3-4MMSTRYKER OSTEOSYNTHESIS-SELZACH2013-06-19
PIN TO ROD COUPLING HOFFMANN II COMPACT 5/3-4MMSTRYKER OSTEOSYNTHESIS-SELZACH2013-06-04
COMPRESSION/DISTRACTION INSTRUMENTSYNTHES GMBH2013-04-23
BREMER 3D CROWN FULL ASSEMBLYDEPUY SYNTHES SPINE2013-04-02
5 HOLE PIN CLAMP HOFFMANN IISTRYKER OSTEOSYNTHESIS-SELZACH2013-03-20
UNKUNKUNK2013-02-01
COMPRESSION/DISTRACTION DEVICE F/FOOT+ANSYNTHES GMBH2013-01-08
BREMER HALO CROWN WITH SKULL PINSDEPUY SYNTHES SPINE2012-12-10
OUTER RAIL FOR PELVIC C-CLAMP IISYNTHES GMBH2012-12-04
THREADED TUBE FOR PELVIC C-CLAMP IISYNTHES GMBH2012-12-04
PELVIC C-CLAMP IISYNTHES GMBH2012-11-30
PELVIC C-CLAMP IISYNTHES GMBH2012-11-30
EXTERNAL FIXATORSYNTHES USA2012-11-27
BREMER LARGE PEDIATRIC RINGDEPUY RAYNHAM2012-10-30
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