JEY
THE BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY
- Advisory panel
- Dental
- Total cleared
- 292
Adverse events under product code JEY
product code JEY- Injury
- 1,542
- Malfunction
- 2,292
- Total
- 3,834
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code JEY
1–100 of 292- K252246 — Leforte MMF System
- K253373 — Southern Craniomaxillofacial (CMF) System
- K251441 — Inion CPS 1.5 Baby Bioabsorbable Fixation System; Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System
- K241314 — KLS Martin Oral-Max Implants MR Conditional (bundled)
- K240651 — MRI Universal
- K233874 — tmCMF Solution
- K232889 — METICULY Patient-specific titanium maxillofacial mesh implant
- K232350 — Stryker Facial iD System
- K230398 — MedCAD® AccuPlate® 3DTi Patient-Specific Plating System
- K230733 — Stryker Resorbable Fixation System
- K222650 — Stryker Cutomized Mandible Recon Plate; Stryker Surgeon iD Mandible Recon Plate
- K220360 — Tandry CMF Plate System
- K221855 — Universal CMF System
- K210731 — KLS Martin Individual Patient Solutions
- K213777 — Stryker Resorbable Fixation System
- K202969 — Biomet Microfixation OmniMax MMF System
- K202918 — OsteoSync Ti Dental Mesh
- K203282 — TECHFIT Patient-Specific Maxillofacial System
- K193280 — MedCAD® AccuPlate® Patient-Specific Plate
- K201944 — DePuy Synthes 2.4mm Ti Self-Tapping MatrixMANDIBLE Screws (26-40mm)
- K182759 — BoniPlus Dental G-Mesh System
- K192747 — Yxoss CBR®
- K191997 — FAICO CMF System
- K193136 — Stryker Customized Mandible Recon Plate Kit
- K193143 — Stryker Facial iD Plating System
- K192655 — Depuy Synthes Maxillofacial Portfolio - MR Conditional
- K182758 — MCI - CMF System
- K191028 — KLS Martin Individual Patient Solutions
- K190696 — Stryker Surgeon iD Mandible Recon Plate
- K182609 — Delphos Implants Rigid Fixation System
- K182305 — Stryker Facial iD Plating System
- K180204 — CranioMaxillofacial Fixation (CMF) System - CMF Visionare
- K180249 — OmniPore DUROMAX Surgical Implants
- K180962 — KLS Martin Individual Patient Solutions
- K173039 — TruMatch CMF Titanium 3D Printed Implant
- K170697 — GBR system
- K172354 — OssBuilder System
- K173320 — KLS Martin L1 MMF System
- K163579 — KLS Martin Individual Patient Solutions
- K170773 — Stryker Universal Mesh
- K172572 — Stryker Upper-Face AXS screws and Mid-Face AXS screws
- K170272 — TruMatch CMF Titanium 3D Printed Implant System
- K171364 — MP LeFort I Plates
- K160363 — OPTIMUS CMF SYSTEM
- K152326 — Biomet Microfixation OmniMax MMF System
- K150965 — LeForte System II
- K143730 — GBR System
- K142568 — Stryker MEDPOR TITAN 3D Orbital Floor Implant
- K143336 — Biomet Microfixation OmniMax MMF System
- K143338 — Argulated Locking Plates
- K140037 — OPTIMUS CMF SYSTEM
- K140978 — OSTEOMED LOW PROFILE ORBITAL FLOOR PLATE SYSTEM
- K141764 — TRISTAR BONE GRAFT FIXATION SYSTEM
- K141165 — MATRIXWAVE MMF SYSTEM
- K133461 — STRYKER UNIVERSAL ORBITAL FLOOR SYSTEM
- K133304 — RXG DISTRACTION SYSTEM
- K121235 — LEIBINGER ADVANCE INTERNAL MIDFACE DISTRACTION SYSTEM
- K132519 — STRYKER CUSTOMIZED MANDIBLE RECON PLATE KIT
- K132600 — FACIAL PREBENT PLATING WITH VIRTUAL SURGICAL PLANNING
- K131289 — I-GEN
- K130840 — SMARTBUILDER SYSTEM (SB1)
- K131674 — PREBENT PLATING WITH VIRTUAL SURGICAL PLANNING
- K123786 — STRYKER UNIVERSAL ORBITAL FLOOR SYSTEM
- K122647 — SYNTHES PATIENT SPECIFIC PLATE
- K122890 — INION CPS ORBITAL PLATES
- K113567 — SYNTHES MATRIXMADIBLE PLATE AND SCREW SYSTEM
- K122313 — STRYKER UNIVERSAL SMARTLOCK HYBRID MMF SYSTEM
- K120951 — SMARTBUILDER SYSTEM
- K121589 — BIOMET MICROFIXATION FACIAL PLATING SYSTEM
- K113512 — BIOMET MICROFIXATION MANDIBULAR FRACTURE/ RECONSTRUCTION DEVICES AND PREBENT PLATES SYSTEM
- K121574 — SYNTHES MATRIXMADIBLE PLATE AND SCREW SYSTEM
- K120271 — ARTISAN SPACE MAINTENANCE SYSTEM
- K112457 — LEFORTE SYSTEM BONE PLATE & SCREW
- K112064 — RESORB X-G
- K111761 — NEO TITANIUM MESH, CTI-MEM
- K113251 — SYNTHES MATRIXMANDIBLE PERFORMED RECONSTRUCTION PLATES
- K110926 — BONE PLATE; BONE SCREW
- K110259 — ARCHITEX SPACE MAINTENANCE SYSTEM
- K103136 — SURGICASE CMF, SURGICASE CONNECT, SURGICASE GUIDE
- K103778 — LEFORTE NEURO SYSTEM BONE PLATE
- K102641 — MINI AND MICRO FRAGMENTS RECONSTRUCTION SYSTEM-NEOFACE
- K102656 — SYNTHES DENTOALVEOLAR BONE FIXATION SYSTEM
- K100779 — SUSTAIN SPACE MAINTENANCE SYSTEM
- K091807 — MEDPOR FIXATION SYSTEM
- K091812 — FRONTIER DEVICES CRANIOMAXILLOFACIAL, CRANIO CLOSURE, ORTHOGNATHIC, MANDIBLE RECONSTRUCTION AND MESH SYSTEMS
- K092743 — THE LEIBINGER ADVANCE INTERNAL MIDFACE DISTRACTION SYSTEM
- K091233 — SYNTHES MATRIXMANDIBLE SUBCONDYLAR PLATES
- K091679 — LEFORTE SYSTEM BONE PLATE
- K091144 — SYNTHES MATRIXMANDIBLE PREFORMED RECONSTRUCTION PLATES
- K083388 — SYNTHES MATRIXORTHOGNATHIS FIXATION SYSTEM
- K082335 — SYNTHES MATRIXMANDIBLE PLATE AND SCREW SYSTEM
- K073307 — MAX-FACE MAXILLOFACIAL OSTEOSYNTHESIS SYSTEM
- K082757 — MODIFIED STERILE PLATE & SCREW KIT CONFIGURATIONS FOR USE WITH BIOPLATE TITANIUM FIXATION SYSTEM
- K080862 — SONICWELD RX (RESORB-X)
- K080694 — OSTEOMED MODULAR LOCKING FIXATION SYSTEM
- K081067 — FRACTURE/RECONSTRUCTION SYSTEM (TRAUMAONE)
- K080331 — SYNTHES CRANIOFACIAL PLATE AND SCREW SYSTEM
- K072528 — ADJUSTABLE BONE PLATES BIOABSORBABLE, SELF COMPRESSION BONE FIXATION SYSTEM & ACCESSORIES
- K072463 — SATYRNE INTERFLEX MANDIBULAR FIXATION SYSTEM
- K071612 — MODUS TRILOCK 2.0/2.3/2.5
Data sourced from openFDA. This site is unofficial and independent of the FDA.