FDA.reportPublic FDA data

ANKLE HINDFOOT NAILING SYSTEM

Primary DI
18053340347372
Brand
ANKLE HINDFOOT NAILING SYSTEM
Company
ORTHOFIX SRL
Model
1
Catalog number
99-T772301
Device description
ANKLE HINDFOOT REVISION NAIL TI L300MM D12MM STERILE WITH GUIDE JIG
Published
2021-05-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
K141571000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K141571000ORTHOFIX ANKLE HINDFOOT NAILING SYSTEMOrthofix Srl2014-11-12HSB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
18053340347372PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1805334034737218053340347372

GMDN Terms#

Term, Definition table
TermDefinition
Arthrodesis nail, sterileA sterile rod made of metal or other material (e.g., carbon fibre) designed to be inserted into the intramedullary canal of any long bone [e.g., femur, tibia, humerus (including fixation of the glenoid), talus, fibula, radius, ulna] to immobilize by holding the ends of a fractured or diseased bone together (i.e., in position) for the purpose of joint fusion or arthrodesis (an operation to permanently fix a joint in position). The device is used for traumatic repair or reconstructive procedures; it may include screws if locked into place. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length300Millimeter
Outer Diameter12Millimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+39456719000info@orthofix.it

Regulatory Flags#

DUNS number
438793622
Device count
1
Lot or batch
true
Serial number
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

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