FDA.reportPublic FDA data

Truelok System

Primary DI
18033509853821
Brand
Truelok System
Company
ORTHOFIX SRL
Model
1
Catalog number
54-1215
Device description
TL,WIRE, W/STOPPER, 1.8MM X 400MM
Published
2016-09-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
18033509853821PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1803350985382118033509853821

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone wireA wire intended for the fixation of bone fractures that may be implanted or used short-term (e.g., to hold a plate in the correct position during an intervention). It may be used: 1) as a cerclage wire to aid bone fixation; 2) in a loop or figure-of-eight configuration to reattach, e.g., the tip of the elbow (olecranon), tibial tubercle, or greater trochanter; 3) to augment bone screw/plate fixation; or 4) as a Kirschner wire or K-Wire to stiffen (arthrodese) a toe or finger. It is made of metal [e.g., stainless steel, cobalt-chrome (Co-Cr)], and may be malleable or rigid; some types include a nut designed to be attached to the wire to prevent wire migration. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length400Millimeter
Outer Diameter1.8Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+039456719000info@orthofix.it

Regulatory Flags#

DUNS number
438793622
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
18059015376111Fitbone Trochanteric99-O4OL18B1099-O4OL18B102025-07-14
18059015376739TRUELOK SYSTEM50-251550-25152025-07-14
18059015376746TRUELOK SYSTEM50-251650-25162025-07-14
18059015376753TRUELOK SYSTEM50-251750-25172025-07-14
18052469476055MINI-FIXATION SYSTEMS1M1462022-12-27
18052469476086MINI-FIXATION SYSTEMS199-M1462022-12-27
18052469476406MINI-FIXATION SYSTEMS199-M14602022-12-27
18053504362852VIEW PLATING SYSTEM - REDUCE FRACTURE PLATING SYSTEM1002-N-202082019-07-17
18053504362869VIEW PLATING SYSTEM - REDUCE FRACTURE PLATING SYSTEM1002-N-202102019-07-17
18053504362876VIEW PLATING SYSTEM - REDUCE FRACTURE PLATING SYSTEM1002-N-202122019-07-17
18053504362883VIEW PLATING SYSTEM - REDUCE FRACTURE PLATING SYSTEM1002-N-202142019-07-17
18053504362890VIEW PLATING SYSTEM - REDUCE FRACTURE PLATING SYSTEM1002-N-202162019-07-17
18053504362906VIEW PLATING SYSTEM - REDUCE FRACTURE PLATING SYSTEM1002-N-202182019-07-17
18053504362913VIEW PLATING SYSTEM - REDUCE FRACTURE PLATING SYSTEM1002-N-202202019-07-17
18053504362920VIEW PLATING SYSTEM - REDUCE FRACTURE PLATING SYSTEM1002-N-202222019-07-17
18053504362937VIEW PLATING SYSTEM - REDUCE FRACTURE PLATING SYSTEM1002-N-202242019-07-17
18053504362944VIEW PLATING SYSTEM - REDUCE FRACTURE PLATING SYSTEM1002-N-202262019-07-17
18053504362951VIEW PLATING SYSTEM - REDUCE FRACTURE PLATING SYSTEM1002-N-202282019-07-17
18053504362968VIEW PLATING SYSTEM - REDUCE FRACTURE PLATING SYSTEM1002-N-202302019-07-17
18053504362975VIEW PLATING SYSTEM - REDUCE FRACTURE PLATING SYSTEM1002-N-202322019-07-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00889024700116CROSSLOCK NARROW BLOCK LEFTBiomet Orthopedics, LLCLXT2025-12-01
00889024700123CROSSLOCK STD BLOCK RIGHTBiomet Orthopedics, LLCLXT2025-12-01
00889024700130CROSSLOCK NARROW BLOCK RIGHTBiomet Orthopedics, LLCLXT2025-12-01
00889024700147CROSSLOCK WIDE BLOCK RIGHTBiomet Orthopedics, LLCLXT2025-12-01
00889024700154CROSSLOCK STD BLOCK LEFTBiomet Orthopedics, LLCLXT2025-12-01
00889024700161CROSSLOCK WIDE BLOCK LEFTBiomet Orthopedics, LLCLXT2025-12-01
09348215127558CR Peg Multi ToolSIGNATURE ORTHOPAEDICS PTY LTDLXT2025-04-09
18052469475966ORTHOFIXORTHOFIX SRLLXT2024-01-31
00885556819791UNI-CP Compression PlateSmith & Nephew, Inc.LXT2023-10-26
18053504366850TRUELOK SYSTEMORTHOFIX SRLLXT2023-07-31
18053504366867TRUELOK SYSTEMORTHOFIX SRLLXT2023-07-31
00841506105734IJS-ESKELETAL DYNAMICS L.L.C.LXT2023-06-20
00841506107226IJS-ESKELETAL DYNAMICS L.L.C.LXT2023-06-20
00841506114859IJS-E (Twin)SKELETAL DYNAMICS L.L.C.LXT2023-06-20
00841506130767IJSSKELETAL DYNAMICS L.L.C.LXT2023-06-20
00841506131559IJSSKELETAL DYNAMICS L.L.C.LXT2023-06-20
00841506132877IJSSKELETAL DYNAMICS L.L.C.LXT2023-06-20
00841506132891IJSSKELETAL DYNAMICS L.L.C.LXT2023-06-20
00841506132907IJSSKELETAL DYNAMICS L.L.C.LXT2023-06-20
00841506132914IJSSKELETAL DYNAMICS L.L.C.LXT2023-06-20
00841506132938IJSSKELETAL DYNAMICS L.L.C.LXT2023-06-20
18052469476437TRUELOK SYSTEMORTHOFIX SRLLXT2023-04-28
00885556839942Total Wrist Fusion SystemSmith & Nephew, Inc.LXT2022-12-21
00885556839966Total Wrist Fusion SystemSmith & Nephew, Inc.LXT2022-12-21
00885556839973Total Wrist Fusion SystemSmith & Nephew, Inc.LXT2022-12-21
00885556839980Total Wrist Fusion SystemSmith & Nephew, Inc.LXT2022-12-21
00885556840009Total Wrist Fusion SystemSmith & Nephew, Inc.LXT2022-12-21
00885556840023Total Wrist Fusion SystemSmith & Nephew, Inc.LXT2022-12-21
00885556840030Total Wrist Fusion SystemSmith & Nephew, Inc.LXT2022-12-21
00885556840047Total Wrist Fusion SystemSmith & Nephew, Inc.LXT2022-12-21