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Panels › Dental › Product code JEY · Class 2

Plate, Bone

Regulation 872.4760

5510(k)s in 12 months (294 all time)
0recalls in 12 months (111 all time)
27recalls that name a 510(k)
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Top companies in JEY

DateFirm and productCodeLinked 510(k)
Aug 3, 2023Materialise N.V.
ProPlan CMF Patient-Specific Guide, Mandible guides (3A & 3B)-Intended to guide the marking of bone and/or guide surgical instruments in mandibular and maxillofacial surgical procedures. Identificatio
Completed
JEYK103136
Dec 17, 2020Biomet, Inc.
Sterile Trac System Thinflap 24 MM Burr Hole Plate, Item number SP-STA-1021-12 - Product Usage: Fixation of Cranial bone
Terminated
JEYK972322
Jun 18, 2020Synthes, Inc.
MatrixNEURO Screws - Product Usage: The intended use for this device is in fixation of cranial bones and facial skeleton in procedures such as craniotomies, reconstructive procedures, fracture repair,
Terminated
JEYK042365
Jun 16, 2020Synthes Produktions GmbH
MatrixMIDFACE Screws - Product Usage: The intended use for this device is in fixation of cranial bones and facial skeleton in procedures such as craniotomies, reconstructive procedures, fracture repai
Terminated
JEYK050608
Feb 3, 2020Materialise N.V.
TRUMATCH Orthognathics - Genioplasty Surgical Kit, Add-on, Catalog Number: SD980.013
Terminated
JEYK170272
Feb 3, 2020Materialise N.V.
TRUMATCH Orthognathic - Full Bimaxillary Surgical Kit, Catalog Number SD980.001
Terminated
JEYK170272
May 7, 2018Zimmer Biomet, Inc.
Lactosorb RapidFlap, bone plate, Model No. 915-0020 The RapidFlap LS Cranial Fixation System is indicated for use in pediatric craniotomy flap fixation.
Terminated
JEYK003281
Jun 7, 2016Synthes (USA) Products LLC
1.5 mm Rapid Resorb Orbt1 F1 P1 w/Bending Template / 35 mm - Sterile, Rapid Resorbable Fixation System. 1.5 mm Rapid Resorbable Orbital Floor Plate with Bending Template. Intended for use in fractu
Terminated
JEYK030069
K062789
Jun 7, 2016Synthes (USA) Products LLC
1.5 mm Rapid Resorb Orbt1 F1 P1 w/Bending Template / 30 mm - Sterile, Rapid Resorbable Fixation System. 1.5 mm Rapid Resorbable Orbital Floor Plate with Bending Template. Intended for use in fractu
Terminated
JEYK030069
K062789
Jun 7, 2016Synthes (USA) Products LLC
1.5 mm Rapid Resorb Orbt1 F1 P1 w/Bending Template / 24 mm - Sterile, Rapid Resorbable Fixation System. 1.5 mm Rapid Resorbable Orbital Floor Plate with Bending Template. Intended for use in frac
Terminated
JEYK030069
K062789
Jul 28, 2015Synthes (USA) Products LLC
Synthes TI Matrix Pre-Bent Maxillary Plate / 2mm ADVMNT/0.8mm THK/L and Synthes TI Matrix Pre-Bent Maxillary Plate / 2mm ADVMNT/0.8mm THK/R. The Synthes Matrix ORTHOGNATHIC Fixation System is intende
Terminated
JEYK083388
Mar 12, 2013Synthes USA HQ, Inc.
Synthes Titanium Midface Distractor, MR Conditional, Part number 487.982. For temporary stabilization and gradual lengthening of the cranial or midfacial bones.
Terminated
JEYK010499
Mar 23, 2012Biomet Microfixation, LLC
Product is labeled in part: "***REF: 01-7036, LOT 999999, "1.5MM" SYSTEM PLATE L-SHAPE, 3 X 3 HOLE, 100 DEGREE, QTY 00001, CE 0086, 2010-04 *** NON-STERILE PRODUCT ***, LEFT, X-LONG, 0.6 MM TITANIUM
Terminated
JEYK953385
Jan 11, 2012Walter Lorenz Surgical, Inc.
Product is 35mm Flex Tube***NON-STERILE PRODUCT***CAUTION: FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN." W.LORENZ SURGICAL***WALTER LORENZ SURGICAL, INC. 1520 TRADEPOR
Terminated
JEYK002083
Jan 11, 2012Walter Lorenz Surgical, Inc.
Product is 65mm Flexible Tube***NON-STERILE PRODUCT***CAUTION: FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN." W.LORENZ SURGICAL***WALTER LORENZ SURGICAL, INC. 1520 TRAD
Terminated
JEYK002083
Jan 11, 2012Walter Lorenz Surgical, Inc.
Product is 40mm Flexible Tube. ***NON-STERILE PRODUCT***CAUTION: FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN." W.LORENZ SURGICAL***WALTER LORENZ SURGICAL, INC. 1520 T
Terminated
JEYK002083
Nov 1, 2011Bioplate Inc
Bioplate Titanium Fixation System, Sterile Kit. The sterile plate and screw kit configurations for use with the Bioplate Titanium Fixation System are intended for use on non-load bearing fixation, in
Terminated
JEYK082757
May 27, 2011Biomet Microfixation, Inc.
***BIOMET MICROFIXATION BIOMET MICROFIXATION 1520 TRADEPORT DRIVE JACKSONVILLE, FL 32218 USA www.biometmicrofixation.com***6 HOLE REGULAR DOUBLE Y PLATE***"1.5MM SYSTEM PLATE DOUBLE Y-SHAPE, REGULAR 0
Terminated
JEYK953385
Dec 16, 2010Stryker Craniomaxillofacial Division
2.8 mm Inion CPS, 2.8 x 18 mm screw, REF SCR-1301, sterile, Manufacturer, INION Oy, Finland.
Terminated
JEYNone listed
Dec 16, 2010Stryker Craniomaxillofacial Division
2.8 mm Inion CPS, 2.8 x 16 mm screw, REF SCR-1300, sterile, Manufacturer, INION Oy, Finland.
Terminated
JEYNone listed
Dec 16, 2010Stryker Craniomaxillofacial Division
2.8 mm Inion CPS, 2.8 x 14 mm screw, REF SCR-1299, sterile, Manufacturer, INION Oy, Finland.
Terminated
JEYNone listed
Dec 16, 2010Stryker Craniomaxillofacial Division
2.8 mm Inion CPS, 2.8 x 12 mm screw, REF SCR-1298, sterile, Manufacturer, INION Oy, Finland.
Terminated
JEYNone listed
Dec 16, 2010Stryker Craniomaxillofacial Division
2.8 mm Inion CPS, 2.8 x 10 mm screw, REF SCR-1297, sterile, Manufacturer, INION Oy, Finland.
Terminated
JEYNone listed
Dec 16, 2010Stryker Craniomaxillofacial Division
2.5 mm Inion CPS, 2.5 x 18 mm screw, REF SCR-1294, sterile, Manufacturer, INION Oy, Finland.
Terminated
JEYNone listed
Dec 16, 2010Stryker Craniomaxillofacial Division
2.5 mm Inion CPS, 2.5 x 16 mm screw, REF SCR-1293, sterile, Manufacturer, INION Oy, Finland.
Terminated
JEYNone listed
Dec 16, 2010Stryker Craniomaxillofacial Division
2.5 mm Inion CPS, 2.5 x 14 mm screw, REF SCR-1292, sterile, Manufacturer, INION Oy, Finland.
Terminated
JEYNone listed
Dec 16, 2010Stryker Craniomaxillofacial Division
2.5 mm Inion CPS, 2.5 x 12 mm screw, REF SCR-1291, sterile, Manufacturer, INION Oy, Finland.
Terminated
JEYNone listed
Dec 16, 2010Stryker Craniomaxillofacial Division
2.5 mm Inion CPS, 2.5 x 10 mm screw, REF SCR-1290, sterile, Manufacturer, INION Oy, Finland.
Terminated
JEYNone listed
Dec 16, 2010Stryker Craniomaxillofacial Division
2.0 mm Inion CPS, 2.0 x 20 mm screw, REF SCR-1289, sterile, Manufacturer, INION Oy, Finland.
Terminated
JEYNone listed
Dec 16, 2010Stryker Craniomaxillofacial Division
2.0 mm Inion CPS, 2.0 x 17 mm screw, REF SCR-1288, sterile, Manufacturer, INION Oy, Finland.
Terminated
JEYNone listed
Dec 16, 2010Stryker Craniomaxillofacial Division
2.0 mm Inion CPS, 2.0 x 15 mm screw, REF SCR-1287, sterile, Manufacturer, INION Oy, Finland.
Terminated
JEYNone listed
Dec 16, 2010Stryker Craniomaxillofacial Division
2.0 mm Inion CPS, 2.0 x 13 mm screw, REF SCR-1286, sterile, Manufacturer, INION Oy, Finland.
Terminated
JEYNone listed
Dec 16, 2010Stryker Craniomaxillofacial Division
2.0 mm Inion CPS, 2.0 x 11 mm screw, REF SCR-1285, sterile, Manufacturer, INION Oy, Finland.
Terminated
JEYNone listed
Dec 16, 2010Stryker Craniomaxillofacial Division
2.0 mm Inion CPS, 2.0 x 9 mm screw, REF SCR-1284, sterile, Manufacturer, INION Oy, Finland.
Terminated
JEYNone listed
Dec 16, 2010Stryker Craniomaxillofacial Division
2.5 mm Inion CPS, 2.5 x 18 mm screw, REF SCR-1243, sterile, Manufacturer, INION Oy, Finland.
Terminated
JEYNone listed
Dec 16, 2010Stryker Craniomaxillofacial Division
2.5 mm Inion CPS, 2.5 x 16 mm screw, REF SCR-1242, sterile, Manufacturer, INION Oy, Finland.
Terminated
JEYNone listed
Dec 16, 2010Stryker Craniomaxillofacial Division
2.5 mm Inion CPS, 2.5 x 14 mm screw, REF SCR-1241, sterile, Manufacturer, INION Oy, Finland.
Terminated
JEYNone listed
Dec 16, 2010Stryker Craniomaxillofacial Division
2.5 mm Inion CPS, 2.5 x 12 mm screw, REF SCR-1240, sterile, Manufacturer, INION Oy, Finland.
Terminated
JEYNone listed
Dec 16, 2010Stryker Craniomaxillofacial Division
2.5 mm Inion CPS, 2.5 x 10 mm screw, REF SCR-1239, sterile, Manufacturer, INION Oy, Finland.
Terminated
JEYNone listed
Dec 16, 2010Stryker Craniomaxillofacial Division
3.1 mm Inion CPS, 3.1 x 18 mm screw, REF SCR-1230, sterile, Manufacturer, INION Oy, Finland.
Terminated
JEYNone listed
Dec 16, 2010Stryker Craniomaxillofacial Division
3.1 mm Inion CPS, 3.1 x 16 mm screw, REF SCR-1229, sterile, Manufacturer, INION Oy, Finland.
Terminated
JEYNone listed
Dec 16, 2010Stryker Craniomaxillofacial Division
3.1 mm Inion CPS, 3.1 x 14 mm screw, REF SCR-1228, sterile, Manufacturer, INION Oy, Finland.
Terminated
JEYNone listed
Dec 16, 2010Stryker Craniomaxillofacial Division
3.1 mm Inion CPS, 3.1 x 12 mm screw, REF SCR-1227, sterile, Manufacturer, INION Oy, Finland.
Terminated
JEYNone listed
Dec 16, 2010Stryker Craniomaxillofacial Division
3.1 mm Inion CPS, 3.1 x 10 mm screw, REF SCR-1226, sterile, Manufacturer, INION Oy, Finland.
Terminated
JEYNone listed
Dec 16, 2010Stryker Craniomaxillofacial Division
2.0 mm Inion CPS, 2.0 x 7 mm screw, REF SCR-1225, sterile, Manufacturer, INION Oy, Finland.
Terminated
JEYNone listed
Dec 16, 2010Stryker Craniomaxillofacial Division
2.0 mm Inion CPS, 2.0 x 5 mm screw, REF SCR-1224, sterile, Manufacturer, INION Oy, Finland.
Terminated
JEYNone listed
Dec 16, 2010Stryker Craniomaxillofacial Division
1.5 mm Inion CPS, 1.5 x 6 mm screw, REF SCR-1223, sterile, Manufacturer, INION Oy, Finland.
Terminated
JEYNone listed
Dec 16, 2010Stryker Craniomaxillofacial Division
1.5 mm Inion CPS, 1.5 x 4 mm screw, REF SCR-1222, sterile, Manufacturer, INION Oy, Finland.
Terminated
JEYNone listed
Dec 16, 2010Stryker Craniomaxillofacial Division
1.5 mm Inion CPS Baby, 1.5 x 6 mm screw, REF SCR-1221, sterile, Manufacturer, INION Oy, Finland.
Terminated
JEYNone listed
Dec 16, 2010Stryker Craniomaxillofacial Division
1.5 mm Inion CPS Baby, 1.5 x 4 mm screw, REF SCR-1220, sterile, Manufacturer, INION Oy, Finland.
Terminated
JEYNone listed

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