Plate, Bone
FDA product code JEY · 281 cleared devices
Class 2
Dental
- Regulation
- 21 CFR 872.4760
- Review panel
- DE
- Implant
- Yes
- Life sustaining
- No
- Third party review
- No
- GMP exempt
- No
- Clearance span
- 1984-06-19 – 2026-08-17
JEY
2026-08-17
JEY
2026-07-25
METICULY Patient-specific CMF solution
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JEY
2026-04-02
Leforte MMF System
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JEY
2025-12-19
Southern Craniomaxillofacial (CMF) System
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JEY
2025-11-07
Inion CPS 1.5 Baby Bioabsorbable Fixation System; Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System
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JEY
2024-08-16
KLS Martin Oral-Max Implants MR Conditional (bundled)
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JEY
2024-07-12
MRI Universal
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JEY
2024-07-11
tmCMF Solution
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JEY
2024-04-30
METICULY Patient-specific titanium maxillofacial mesh implant
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JEY
2024-01-13
Stryker Facial iD System
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JEY
2023-09-26
MedCAD® AccuPlate® 3DTi Patient-Specific Plating System
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JEY
2023-08-05
Stryker Resorbable Fixation System
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JEY
2022-12-09
Stryker Cutomized Mandible Recon Plate; Stryker Surgeon iD Mandible Recon Plate
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JEY
2022-11-10
Tandry CMF Plate System
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JEY
2022-11-09
Universal CMF System
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JEY
2022-07-18
KLS Martin Individual Patient Solutions
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JEY
2022-02-04
Stryker Resorbable Fixation System
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JEY
2021-08-05
Biomet Microfixation OmniMax MMF System
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JEY
2021-07-14
OsteoSync™ Ti Dental Mesh
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JEY
2021-05-19
TECHFIT Patient-Specific Maxillofacial System
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JEY
2021-02-12
MedCAD® AccuPlate® Patient-Specific Plate
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JEY
2020-09-10
DePuy Synthes 2.4mm Ti Self-Tapping MatrixMANDIBLE Screws (26-40mm)
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JEY
2020-07-29
BoniPlus Dental G-Mesh System
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JEY
2020-06-17
Yxoss CBR®
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JEY
2020-04-22
FAICO CMF System
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JEY
2020-03-26
Stryker Facial iD Plating System
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JEY
2020-03-26
Stryker Customized Mandible Recon Plate Kit
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JEY
2019-12-30
Depuy Synthes Maxillofacial Portfolio - MR Conditional
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JEY
2019-12-05
MCI - CMF System
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JEY
2019-11-22
KLS Martin Individual Patient Solutions
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JEY
2019-06-28
Stryker Surgeon iD Mandible Recon Plate
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JEY
2019-03-29
Delphos Implants Rigid Fixation System
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JEY
2019-01-07
Stryker Facial iD Plating System
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JEY
2018-12-28
CranioMaxillofacial Fixation (CMF) System - CMF Visionare
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JEY
2018-10-11
OmniPore DUROMAX Surgical Implants
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JEY
2018-08-13
KLS Martin Individual Patient Solutions
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JEY
2018-07-10
TruMatch CMF Titanium 3D Printed Implant
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JEY
2018-05-24
GBR system
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JEY
2018-03-26
OssBuilder System
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JEY
2018-02-23
KLS Martin L1 MMF System
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JEY
2017-11-21
KLS Martin Individual Patient Solutions
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JEY
2017-11-08
Stryker Universal Mesh
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JEY
2017-10-31
Stryker Upper-Face AXS screws and Mid-Face AXS screws
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JEY
2017-08-08
TruMatch CMF Titanium 3D Printed Implant System
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JEY
2017-07-24
MP LeFort I Plates
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JEY
2016-10-20
OPTIMUS CMF SYSTEM
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JEY
2013-12-06
STRYKER CUSTOMIZED MANDIBLE RECON PLATE KIT
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JEY
2013-10-02
FACIAL PREBENT PLATING WITH VIRTUAL SURGICAL PLANNING
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JEY
2013-09-25
I-GEN
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JEY
2013-09-18
SMARTBUILDER SYSTEM (SB1)
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JEY
2013-08-08
PREBENT PLATING WITH VIRTUAL SURGICAL PLANNING
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JEY
2013-04-09
STRYKER UNIVERSAL ORBITAL FLOOR SYSTEM
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JEY
2013-02-28
SYNTHES PATIENT SPECIFIC PLATE
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JEY
2013-01-29
INION CPS ORBITAL PLATES
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JEY
2012-11-19
SYNTHES MATRIXMADIBLE PLATE AND SCREW SYSTEM
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JEY
2012-10-31
STRYKER UNIVERSAL SMARTLOCK HYBRID MMF SYSTEM
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JEY
2012-10-03
SMARTBUILDER SYSTEM
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JEY
2012-09-21
BIOMET MICROFIXATION FACIAL PLATING SYSTEM
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JEY
2012-06-29
SYNTHES MATRIXMADIBLE PLATE AND SCREW SYSTEM
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JEY
2012-06-29
BIOMET MICROFIXATION MANDIBULAR FRACTURE/ RECONSTRUCTION DEVICES AND PREBENT PLATES SYSTEM
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JEY
2012-05-30
ARTISAN SPACE MAINTENANCE SYSTEM
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JEY
2012-05-18
LEFORTE SYSTEM BONE PLATE & SCREW
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JEY
2012-03-23
RESORB X-G
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JEY
2012-01-10
NEO TITANIUM MESH, CTI-MEM
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JEY
2011-12-21
SYNTHES MATRIXMANDIBLE PERFORMED RECONSTRUCTION PLATES
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JEY
2011-12-08
BONE PLATE; BONE SCREW
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JEY
2011-04-13
ARCHITEX SPACE MAINTENANCE SYSTEM
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JEY
2011-03-18
SURGICASE CMF, SURGICASE CONNECT, SURGICASE GUIDE
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JEY
2011-01-26
LEFORTE NEURO SYSTEM BONE PLATE
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JEY
2010-12-20
SYNTHES DENTOALVEOLAR BONE FIXATION SYSTEM
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JEY
2010-12-20
MINI AND MICRO FRAGMENTS RECONSTRUCTION SYSTEM-NEOFACE
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JEY
2010-12-13
SUSTAIN SPACE MAINTENANCE SYSTEM
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JEY
2010-06-28
MEDPOR FIXATION SYSTEM
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JEY
2010-05-07
FRONTIER DEVICES CRANIOMAXILLOFACIAL, CRANIO CLOSURE, ORTHOGNATHIC, MANDIBLE RECONSTRUCTION AND MESH SYSTEMS
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JEY
2010-01-15
THE LEIBINGER ADVANCE INTERNAL MIDFACE DISTRACTION SYSTEM
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JEY
2009-12-11
SYNTHES MATRIXMANDIBLE SUBCONDYLAR PLATES
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JEY
2009-10-02
LEFORTE SYSTEM BONE PLATE
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JEY
2009-08-25
SYNTHES MATRIXMANDIBLE PREFORMED RECONSTRUCTION PLATES
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JEY
2009-03-12
SYNTHES MATRIXORTHOGNATHIS FIXATION SYSTEM
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JEY
2008-11-10
SYNTHES MATRIXMANDIBLE PLATE AND SCREW SYSTEM
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JEY
2008-10-29
MAX-FACE MAXILLOFACIAL OSTEOSYNTHESIS SYSTEM
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JEY
2008-10-01
MODIFIED STERILE PLATE & SCREW KIT CONFIGURATIONS FOR USE WITH BIOPLATE TITANIUM FIXATION SYSTEM
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JEY
2008-07-21
SONICWELD RX (RESORB-X)
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JEY
2008-05-15
OSTEOMED MODULAR LOCKING FIXATION SYSTEM
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JEY
2008-05-09
FRACTURE/RECONSTRUCTION SYSTEM (TRAUMAONE)
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JEY
2008-04-30
SYNTHES CRANIOFACIAL PLATE AND SCREW SYSTEM
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JEY
2007-12-28
ADJUSTABLE BONE PLATES BIOABSORBABLE, SELF COMPRESSION BONE FIXATION SYSTEM & ACCESSORIES
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JEY
2007-11-29
SATYRNE INTERFLEX MANDIBULAR FIXATION SYSTEM
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JEY
2007-09-11
MODUS TRILOCK 2.0/2.3/2.5
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JEY
2007-07-30
SIS SINUS IMPLANT STABILIZER
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JEY
2007-07-25
XSORB BIOABSORBABLE CRANIOFACIAL BONE FIXATION SYSTEM & ACCESSORIES
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JEY
2007-04-16
THE SYNTHES MATRIXMANDIBLE PLATE AND SCREW SYSTEM
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JEY
2007-03-14
OSTEOTRANS -MX BIOABSORBABLE BONE FIXATION SYSTEM
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JEY
2007-02-27
SYNTHES (USA) RAPID RESORBABLE FIXATION SYSTEM
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JEY
2007-01-12
LORENZ TITANIUM FRACTURE / RECONSTRUCTION DEVICES AND PRE-BENT PLATES
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JEY
2006-09-21
SONICWELD RX ENDOBROW FIXATION
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JEY
2006-04-18
KLS MARTIN RIGID FIXATION - STERILE
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JEY
2006-04-07
AESCULAP CRANIOFACIAL PLATE AND SCREW
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JEY
2005-09-20
INION CPS BABY 1.5 BIOABSORBABLE FIXATION SYSTEM
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JEY
2005-08-22
RESORB-X SF
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