FDA.reportPublic FDA data

Leforte Neuro System Bone Screw

Primary DI
08809265155348
Brand
Leforte Neuro System Bone Screw
Company
Jeil Medical Corporation
Model
16-NF-004
Published
2015-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
GWOPlate, Cranioplasty, Preformed, Alterable
GXRCover, Burr Hole
HBWFastener, Plate, Cranioplasty
HWCScrew, Fixation, Bone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GWOPlate, Cranioplasty, Preformed, AlterableNeurology2
GXRCover, Burr HoleNeurology2
HBWFastener, Plate, CranioplastyNeurology2
HWCScrew, Fixation, BoneOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K091686000
K112812000
K141452000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K091686000LEFORTE NEUROSYSTEM BONE SCREWJeil Medical Corporation2009-11-13HWC
K112812000LEFORTE NEURO SYSTEM BONE PLATEJeil Medical Corporation2012-02-22GWO
K141452000LEFORTE NEURO SYSTEM BONE PLATE AND SCREWJeil Medical Corporation2014-07-02GWO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809265155348PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809265155348088092651553488809265155348

GMDN Terms#

Term, Definition table
TermDefinition
Craniofacial bone screw, non-bioabsorbableA small, threaded rod with a slotted head intended to be implanted in craniofacial bone (including the maxilla and/or mandible) for fracture fixation by direct interfragmentary stabilization of bone or by screwing plates in place; it may also be intended for transplanted bone fixation. It may be self-drilling/self-tapping and is made of a material that is not chemically degraded or absorbed via natural body processes [e.g., implant grade metal such as titanium (Ti)]. Its uses include repair of orbital fractures and fractures around the cranial sinuses, paediatric reconstructive surgery, craniotomy flap fixation, bone augmentation procedures.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
688811603
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800089487820Surgical Instrument113-HF-7182026-10-26
08800089483440Surgical InstrumentS111-356-42026-06-10
08800089483464Summa Orthopaedics System Surgical InstrumentSO-S111-356-42026-06-10
08800089483433Drill bit111-6062026-06-10
08800089483457Summa Orthopaedics System Surgical InstrumentSO-111-6062026-06-10
08800089479450ARIX System Bone Screw35N-SO-L20-TA2026-06-01
08800089479467ARIX System Bone Screw35N-SO-L22-TA2026-06-01
08800089479474ARIX System Bone Screw35N-SO-L24-TA2026-06-01
08800089479481ARIX System Bone Screw35N-SO-L26-TA2026-06-01
08800089479498ARIX System Bone Screw35N-SO-L28-TA2026-06-01
08800089479504ARIX System Bone Screw35N-SO-L30-TA2026-06-01
08800089479511ARIX System Bone Screw35N-SO-L32-TA2026-06-01
08800089479528ARIX System Bone Screw35N-SO-L34-TA2026-06-01
08800089479535ARIX System Bone Screw35N-SO-L36-TA2026-06-01
08800089479542ARIX System Bone Screw35N-SO-L38-TA2026-06-01
08800089479559ARIX System Bone Screw35N-SO-L40-TA2026-06-01
08800089479566ARIX System Bone Screw35N-SO-L42-TA2026-06-01
08800089479573ARIX System Bone Screw35N-SO-L44-TA2026-06-01
08800089479580ARIX System Bone Screw35N-SO-L46-TA2026-06-01
08800089479597ARIX System Bone Screw35N-SO-L48-TA2026-06-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00810228570656FUSION SKULL IMPLANTKELYNIAM GLOBAL, INC.GWO2026-10-28
00810228570663CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-10-28
07630894821714APTUSMedartis AGHWC2026-10-27
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