FDA.reportPublic FDA data

ORTHOFIX

Primary DI
18059015373660
Brand
ORTHOFIX
Company
ORTHOFIX SRL
Model
1
Catalog number
99-709265
Device description
FITBONE TROCHANTERIC NAIL L265MM D9MM STERILE
Published
2024-07-05
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Unsafe
Rx
true
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
K233867000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K233867000Fitbone TrochantericOrthofix Srl2024-06-18HSB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
18059015373660PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1805901537366018059015373660

GMDN Terms#

Term, Definition table
TermDefinition
Long bone distraction nail, motorizedAn implantable, electrically-powered device in the form of a 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length265Millimeter
Outer Diameter9Millimeter
Outer Diameter10Millimeter

Sterilization Methods#

Method table
Method

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
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
18059015375831OrthoNext™ Platform System Software2.1ORTHONEXTSW2.12025-01-31
18059015375848OrthoNext™ Platform System Software1.1TLHEXMODULESW1.12025-01-31
18052469476444OrthoNext™ Platform System Software1.0TLHEXMODULESW2023-03-31
18052469476451OrthoNext™ Platform System Software1.0MYHEXPLANSW2023-03-31
18053340345675OrthoNext™ Platform System Software2.0ORTHONEXTSW2023-03-31
18053340345682OrthoNext™ Platform System Software1.1JPSMODULESW2023-03-31
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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