FDA.reportPublic FDA data

MJ-FLEX

Primary DI
18054242518792
Brand
MJ-FLEX
Company
ORTHOFIX SRL
Model
1
Catalog number
166978
Device description
EXTRACTION PLIERS
Published
2018-04-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HTYPin, Fixation, Smooth

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTYPin, Fixation, SmoothOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K173051000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K173051000Orthofix MJ-FLEX THE NEW METAIZEAU NAILOrthofix Srl2017-11-16HTY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
18054242518792PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1805424251879218054242518792

GMDN Terms#

Term, Definition table
TermDefinition
Bone fixation plate pliers insertA small, soft, gripping device inserted into bone fixation plate bending/cutting pliers to hold the free section of a cut implant to prevent it from becoming a projectile when it is cut. The insert is used when modifying an orthopaedic implant, typically a light bone plate [e.g., a 1-2 mm in thickness craniomaxillofacial (CMF) fixation plate being cut to a desired length]. It is typically made of synthetic material (e.g., silicone). This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

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
Sterilization required before use
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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Primary DI, Brand, Company table
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