FDA.report

Truelok System

Primary DI
18033509853579
Brand
Truelok System
Company
ORTHOFIX SRL
Model
1
Catalog number
54-1124
Device description
TL,HALF PIN, TAPERED, SELF THREADED, 5MM X 180MM
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

Related Records

Contact Domains

Product Codes

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

Product Code Classifications

CodeDeviceSpecialtyClass
LXTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal CompositeOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
18033509853579PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1803350985357918033509853579

GMDN Terms

TermDefinition
Orthopaedic bone pin, non-bioabsorbableA small diameter rod typically used for the fixation of a bone fracture or bone grafts, or for an osteotomy or arthrodesis. The rod may be smooth, wholly- or partially-threaded, solid or cannulated, and some designs may be tapered; it is not specific to the clavicle bone. The device is made of a material that is not chemically degraded or absorbed by natural body processes (e.g., implant grade metal, surgical steel, titanium alloy, or carbon fibre). Some designs may have a break-off shank and/or may be coated [e.g., with hydroxyapatite, also known as hydroxylapatite (HA)] to improve purchase in osteoporotic bone and for long-term fixation. This is a single-use device.

Device Sizes

TypeValueUnit
Length180Millimeter
Outer Diameter5Millimeter

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

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

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