FDA.reportPublic FDA data

TRUELOK SYSTEM

Primary DI
18056099649629
Brand
TRUELOK SYSTEM
Company
ORTHOFIX SRL
Model
1
Catalog number
50-1010M
Device description
TL PLUS NYLON INSERT NUT (PACK OF 10)
Published
2018-04-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LXTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal CompositeOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K941048000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K941048000TRUE/LOK MONOLATERAL/BILATERAL FIXATORApplied Osteo Systems, Inc.1994-10-03LXT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
18056099649629PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1805609964962918056099649629

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone nutA sterile profiled block made of metallic or non-metallic material that is threaded on its inside surface, and designed to securely fasten a bone fixation bolt, possibly with a washer. This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+0390456719000info@orthofix.it

Regulatory Flags#

DUNS number
438793622
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
18053504361176TRUELOK SYSTEM154-115602018-04-28
18059015376654MINIRAL1M191-012026-05-04
18059015376661MINIRAL1M191-022026-05-04
18059015376678MINIRAL1M1912026-05-04
18059015376692PENNIG MINIFIXATOR1M444-012026-05-04
18059015376708PENNIG MINIFIXATOR1M444-022026-05-04
18059015376715PENNIG MINIFIXATOR1M4442026-05-04
18059015376784PENNIG DYNAMIC WRIST FIXATOR113761-012026-05-04
18059015376791PENNIG DYNAMIC WRIST FIXATOR113761-022026-05-04
18059015376807PENNIG DYNAMIC WRIST FIXATOR113761-032026-05-04
18059015376814PENNIG DYNAMIC WRIST FIXATOR1137612026-05-04
18054242515173Galaxy UNYCO System199-936732016-07-27
18054242515180Galaxy UNYCO System199-936702016-07-27
18052469476055ORTHOFIX MODULSYSTEM1M1462022-12-27
18052469476086ORTHOFIX MODULSYSTEM199-M1462022-12-27
18052469476406ORTHOFIX MODULSYSTEM199-M14602022-12-27
18053504369721ORTHOFIX GALAXY FIXATION SYSTEM1930402019-05-31
18053504369738ORTHOFIX GALAXY FIXATION SYSTEM1931402019-05-31
18059015375879TrueLok Elevate150-2590C2025-01-03
18059015375909TrueLok Elevate150-25052025-01-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800089416585INLET System Bone ScrewJeil Medical CorporationLXT2021-11-18
08800089416592INLET System Bone ScrewJeil Medical CorporationLXT2021-11-18
08800089416608INLET System Bone ScrewJeil Medical CorporationLXT2021-11-18
08800089416615INLET System Bone ScrewJeil Medical CorporationLXT2021-11-18
08800089416622INLET System Bone ScrewJeil Medical CorporationLXT2021-11-18
08800089416639INLET System Bone ScrewJeil Medical CorporationLXT2021-11-18
08800089416646INLET System Bone ScrewJeil Medical CorporationLXT2021-11-18
08800089416653INLET System Bone ScrewJeil Medical CorporationLXT2021-11-18
08800089416660INLET System Bone ScrewJeil Medical CorporationLXT2021-11-18
08800089416677INLET System Bone ScrewJeil Medical CorporationLXT2021-11-18
08800089416684INLET System Bone ScrewJeil Medical CorporationLXT2021-11-18
10381780065197Integra® Total Wrist Fusion SystemAscension Orthopedics, Inc.LXT2017-10-09
10381780065203Integra® Total Wrist Fusion SystemAscension Orthopedics, Inc.LXT2017-10-09
10381780065210Integra® Total Wrist Fusion SystemAscension Orthopedics, Inc.LXT2017-10-09
10381780065227Integra® Total Wrist Fusion SystemAscension Orthopedics, Inc.LXT2017-10-09
10381780065234Integra® Total Wrist Fusion SystemAscension Orthopedics, Inc.LXT2017-10-09
10381780065241Integra® Total Wrist Fusion SystemAscension Orthopedics, Inc.LXT2017-10-09
10381780065258Integra® Total Wrist Fusion SystemAscension Orthopedics, Inc.LXT2017-10-09
10381780065265Integra® Total Wrist Fusion SystemAscension Orthopedics, Inc.LXT2017-10-09
10381780065272Integra® Total Wrist Fusion SystemAscension Orthopedics, Inc.LXT2017-10-09
10381780065289Integra® Total Wrist Fusion SystemAscension Orthopedics, Inc.LXT2017-10-09
10381780065296Integra® Total Wrist Fusion SystemAscension Orthopedics, Inc.LXT2017-10-09
10381780065302Integra® Total Wrist Fusion SystemAscension Orthopedics, Inc.LXT2017-10-09
10381780065319Integra® Total Wrist Fusion SystemAscension Orthopedics, Inc.LXT2017-10-09
10381780065326Integra® Total Wrist Fusion SystemAscension Orthopedics, Inc.LXT2017-10-09
10381780065333Integra® Total Wrist Fusion SystemAscension Orthopedics, Inc.LXT2017-10-09
10381780065340Integra® Total Wrist Fusion SystemAscension Orthopedics, Inc.LXT2017-10-09
10381780065357Integra® Total Wrist Fusion SystemAscension Orthopedics, Inc.LXT2017-10-09
10381780065364Integra® Total Wrist Fusion SystemAscension Orthopedics, Inc.LXT2017-10-09
10381780065371Integra® Total Wrist Fusion SystemAscension Orthopedics, Inc.LXT2017-10-09