Product Code: JEY


Products Classified as JEY

1277Plate, BoneBone Plate.

Total Product Life Cycle (TPLC) Devices

1277Plate, BoneBone Plate.

FDA Consensus Standards

Plate, Bone [32309]21 CFR §872.4760 🔎
Plate, Bone [34709]21 CFR §872.4760 🔎
Plate, Bone [32013]21 CFR §872.4760 🔎
Plate, Bone [33511]21 CFR §872.4760 🔎
Plate, Bone [37849]21 CFR §872.4760 🔎
Plate, Bone [31922]21 CFR §872.4760 🔎
Plate, Bone [33510]21 CFR §872.4760 🔎
Plate, Bone [21833]21 CFR §872.4760 🔎
Plate, Bone [32004]21 CFR §872.4760 🔎
Plate, Bone [37372]21 CFR §872.4760 🔎
Plate, Bone [35592]21 CFR §872.4760 🔎

Pre-market Notifications for JEY

K222650Stryker Cutomized Mandible Recon Plate; Stryker Surgeon ID Mandible Recon PlateStryker Craniomaxillofacial (CMF)
K221855Universal CMF SystemStryker Leibinger GmbH & Co. KG
K220360Tandry CMF Plate SystemMicroware Precision Co., Ltd.
K213777Stryker Resorbable Fixation SystemStryker Leibinger Micro Implants
K203282TECHFIT Patient-Specific Maxillofacial SystemIndustrias Medicas Sampedro S.A.S.
K202969Biomet Microfixation OmniMax MMF SystemBiomet Microfixation
K202918OsteoSync™ Ti Dental MeshSites Medical, LLC
K201944DePuy Synthes 2.4mm Ti Self-Tapping MatrixMANDIBLE Screws (26-40mm)Synthes (USA) Products, LLC
K193280MedCAD® AccuPlate® Patient-Specific PlateMedCAD
K193136Stryker Customized Mandible Recon Plate KitStryker
K193143Stryker Facial ID Plating SystemStryker
K192747Yxoss CBR®ReOss GmbH
K192655Depuy Synthes Maxillofacial Portfolio - MR ConditionalSynthes (USA) Products LLC
K191997FAICO CMF SystemFAICO Medical LLC
K191028KLS Martin Individual Patient SolutionsKLS-Martin L.P.

Global Unique Device Identification Database

00613994802538PLATE, BONE
00614950008490PLATE, BONE
00614950008483PLATE, BONE
00614950008476PLATE, BONE
00643169590304PLATE, BONE
00673978003061PLATE, BONE
00673978003054PLATE, BONE
00673978003047PLATE, BONE
00721902973048PLATE, BONE
00721902973024PLATE, BONE
00721902569227PLATE, BONE
00721902525476PLATE, BONE
00845694098106PLATE, BONE
00845694094627PLATE, BONE
00845694094610PLATE, BONE

Maude Adverse Events

1.5MM SYSTEM HIGH TORQUE (HT),SD,X-DR,SCR,5/PKBIOMET MICROFIXATION2020-03-30
MAXILLARY DISTRACTOR BODY 15MMOBERDORF SYNTHES PRODUKTIONS GMBH2020-03-27
MAXILLARY DISTRACTOR BODY 15MMOBERDORF SYNTHES PRODUKTIONS GMBH2020-03-27
BONE SCREWS, MP, CROSS-PIN, DIAM.2.0X6MM,(5/PACKAGE)STRYKER LEIBINGER FREIBURG2020-03-25
BONE PLATE, MP, 16 HOLESTRYKER LEIBINGER FREIBURG2020-03-25
LACTOSORB SYSTEM 14MM RAPID FLAPBIOMET MICROFIXATION2020-03-24
TI MATRIXMANDIBLE 12 HOLE PLATE 2.0MM THICKOBERDORF SYNTHES PRODUKTIONS GMBH2020-03-23
2.4MM TI MATRIXMANDIBLE SCREW SELF-TAPPING 6MM.OBERDORF SYNTHES PRODUKTIONS GMBH2020-03-23
2.4MM TI MATRIXMANDIBLE SCREW SELF-TAPPING 6MM.OBERDORF SYNTHES PRODUKTIONS GMBH2020-03-23
2.4MM TI MATRIXMANDIBLE SCREW SELF-TAPPING 10MMOBERDORF SYNTHES PRODUKTIONS GMBH2020-03-23
2.4MM TI MATRIXMANDIBLE SCREW SELF-TAPPING 6MMOBERDORF SYNTHES PRODUKTIONS GMBH2020-03-23
TI MATRIXMANDIBLE 12 HOLE PLATE 2.0MM THICKOBERDORF SYNTHES PRODUKTIONS GMBH2020-03-23
LEVEL ONE CMFKARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG2020-03-17
LEVEL ONE NEUROKARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG2020-03-17
TRUMATCHMATERIALISE NV2020-03-17
1.6MM KIRSCHNER WIRE WITH 5MM THREAD-TROCAR POINT 150MMWRIGHTS LANE SYNTHES USA PRODUCTS LLC2020-03-16
1.5MM SYSTEM HIGH TORQUE (HT),SD,X-DR,SCR,5/PK 1.5MM X 5MMBIOMET MICROFIXATION2020-03-12
TMJ SYSTEM CROSS DRIVE EMERGENCY FOSSA SCREW 2.3MM X 9MMBIOMET MICROFIXATION2020-03-10
TMJ SYSTEM CROSS DRIVE FOSSA SCREW 2.0MM X 9MMBIOMET MICROFIXATION2020-03-10
TMJ SYSTEM CROSS DRIVE FOSSA SCREW 2.0MM X 7MMBIOMET MICROFIXATION2020-03-10
TI MATRIXNEURO DOUBLE Y-PLATE 6 HOLES/21MMWRIGHTS LANE SYNTHES USA PRODUCTS LLC2020-03-06
TI MATRIXNEURO DOUBLE Y-PLATE 6 HOLES/21MMWRIGHTS LANE SYNTHES USA PRODUCTS LLC2020-03-06
TIMESH STRAIGHT PLATE 1H X 1H 8 MMMEDTRONIC NEUROSURGERY2020-03-04
TIMESH STRAIGHT PLATE 1H X 1H 8 MMMEDTRONIC NEUROSURGERY2020-03-04
1.6MM KIRSCHNER WIRE WITH 5MM THREAD-TROCAR POINT 150MMWRIGHTS LANE SYNTHES USA PRODUCTS LLC2020-03-03
UNK - PLATES: MATRIXMANDIBLEOBERDORF SYNTHES PRODUKTIONS GMBH2020-03-03
TMJ SYSTEM CROSS DRIVE FOSSA SCREW 2.0MM X 7MMBIOMET MICROFIXATION2020-03-02
1.5MM SYSTEM HIGH TORQUE (HT),SD,X-DR,SCR,5/PK 1.5MM X 5MMBIOMET MICROFIXATION2020-03-02
LACTOSORB SYSTEM 50 X 50MM X .5MM THICK SHEETINGBIOMET MICROFIXATION2020-02-28
SCR ?1.5 SELF-TAP L5 TAN 1U I/CLIPOBERDORF SYNTHES PRODUKTIONS GMBH2020-02-28
MINI PLATE, 6-HOLES (1/P)STRYKER LEIBINGER FREIBURG2020-02-27
LEVEL ONE CMFKARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG2020-02-26
THINFLAP SYSTEM CROSS-DRIVE, SELF-DRILLING SCREW 1.5X4MMBIOMET MICROFIXATION2020-02-24
MATNEU SCR ?1.5 SELF-DRILL L4 TAN 4U I/COBERDORF SYNTHES PRODUKTIONS GMBH2020-02-24
2.0MM RAPID RESORBABLE CORTEX SCREW 4MM-STERILEWRIGHTS LANE SYNTHES USA PRODUCTS LLC2020-02-24
2.0MM RAPID RESORBABLE CORTEX SCREW 4MM-STERILEWRIGHTS LANE SYNTHES USA PRODUCTS LLC2020-02-24
2.0MM RAPID RESORBABLE STRUT PLATE 2 HOLESX18 HOLES-STERILEWRIGHTS LANE SYNTHES USA PRODUCTS LLC2020-02-24
2.0MM RAPID RESORBABLE CORTEX SCREW 4MM-STERILEWRIGHTS LANE SYNTHES USA PRODUCTS LLC2020-02-21
2.0MM RAPID RESORBABLE CORTEX SCREW 4MM-STERILEWRIGHTS LANE SYNTHES USA PRODUCTS LLC2020-02-21
2.0MM RAPID RESORBABLE STRUT PLATE 2 HOLESX18 HOLES-STERILEWRIGHTS LANE SYNTHES USA PRODUCTS LLC2020-02-21
1.5MM SYSTEM LEFORT PLATE, FLAT 0.6MMBIOMET MICROFIXATION2020-02-19
1.5MM SYSTEM HIGH TORQUE (HT) CROSS-DRIVE SCREW, 5/PKBIOMET MICROFIXATION2020-02-19
1.5MM SYSTEM HIGH TORQUE (HT) CROSS-DRIVE SCREW, 5/PKBIOMET MICROFIXATION2020-02-19
1.5MM SYSTEM PLATE L-SHAPE, 3 X 3 HOLE, 100 DEGREE RIGHT, MEDIUM, 0.6MMBIOMET MICROFIXATION2020-02-19
1.5MM SYSTEM PLATE L-SHAPE, 3 X 3 HOLE, 100 DEGREE LEFT, MEDIUM, 0.6MMBIOMET MICROFIXATION2020-02-19
LEVEL ONE CMFKARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG2020-02-19
TRUMATCHMATERIALISE NV2020-02-19
MATNEU SCR ?1.5 SELF-DRILL L4 TAN 4U I/COBERDORF SYNTHES PRODUKTIONS GMBH2020-02-18
1.5MM SYSTEM HIGH TORQUE (HT) CROSS-DRIVE SCREWBIOMET MICROFIXATION2020-02-14
TRUMATCHMATERIALISE NV2020-02-14

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