FDA.reportPublic FDA data

Fitbone Transport and Lengthening System

Primary DI
18059015378122
Brand
Fitbone Transport and Lengthening System
Company
ORTHOFIX SRL
Model
1
Catalog number
99-60003946
Device description
FITBONE TRANSPORT PULLING NAIL TPN 1380-F-R-390 STERILE
Published
2026-07-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
false
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HSBROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HSBRod, Fixation, Intramedullary And AccessoriesOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K260146000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K260146000FITBONE® TRANSPORT AND LENGTHENING SYSTEMOrthofix Srl2026-05-19HSB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
18059015378122PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1805901537812218059015378122

GMDN Terms#

Term, Definition table
TermDefinition
Long bone distraction intramedullary nail, motorizedAn implantable, electrically-powered device in the form of a rigid rod, capable of extending in length, designed to be inserted into the medullary cavity of a long bone to hold the ends of a fractured bone in position to promote healing, or to correct limb length discrepancies. A rod (nail) is specific to a particular long bone (e.g., femur, humerus, tibia) and is used for traumatic repair or reconstructive procedures (e.g., leg lengthening). It consists of telescoping rods connected to the bone by locking screws, and a small motor to provide lengthening force which is controlled/powered by a remote controller device operating through an implanted receiver.

Contacts#

Phone, Email table
PhoneEmail
+0390456719000info@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
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
18032568033229Surgical Instruments1136202026-07-23
18032568033236Surgical Instruments1136212026-07-23
18032568036008WRIST FIXATION SYSTEMS1360082026-07-23
18059015376838Fitbone Transport and Lengthening System199-600038172026-07-23
18059015376845Fitbone Transport and Lengthening System199-600038182026-07-23
18059015376852Fitbone Transport and Lengthening System199-600038192026-07-23
18059015376869Fitbone Transport and Lengthening System199-600038202026-07-23
18059015376876Fitbone Transport and Lengthening System199-600038212026-07-23
18059015376883Fitbone Transport and Lengthening System199-600038222026-07-23
18059015376890Fitbone Transport and Lengthening System199-600038232026-07-23
18059015376906Fitbone Transport and Lengthening System199-600038242026-07-23
18059015376913Fitbone Transport and Lengthening System199-600038252026-07-23
18059015376920Fitbone Transport and Lengthening System199-600038262026-07-23
18059015376937Fitbone Transport and Lengthening System199-600038272026-07-23
18059015376944Fitbone Transport and Lengthening System199-600038282026-07-23
18059015376951Fitbone Transport and Lengthening System199-600038292026-07-23
18059015376968Fitbone Transport and Lengthening System199-600038302026-07-23
18059015376975Fitbone Transport and Lengthening System199-600038312026-07-23
18059015376982Fitbone Transport and Lengthening System199-600038322026-07-23
18059015376999Fitbone Transport and Lengthening System199-600038332026-07-23

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Primary DI, Brand, Company table
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