MINI-FIXATION SYSTEMS 99-M146

GUDID 18052469476086

CALCFIX PLUS CALCANEAL FIXATOR STERILE

ORTHOFIX SRL

External orthopaedic fixation system, reusable
Primary Device ID18052469476086
NIH Device Record Key8a988382-f36b-4dbf-9d67-e6629c683f96
Commercial Distribution StatusIn Commercial Distribution
Brand NameMINI-FIXATION SYSTEMS
Version Model Number1
Catalog Number99-M146
Company DUNS438793622
Company NameORTHOFIX SRL
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone0456719000
Emailinfo@orthofix.it
Phone0456719000
Emailinfo@orthofix.it
Phone0456719000
Emailinfo@orthofix.it
Phone0456719000
Emailinfo@orthofix.it
Phone0456719000
Emailinfo@orthofix.it
Phone0456719000
Emailinfo@orthofix.it
Phone0456719000
Emailinfo@orthofix.it
Phone0456719000
Emailinfo@orthofix.it
Phone0456719000
Emailinfo@orthofix.it
Phone0456719000
Emailinfo@orthofix.it
Phone0456719000
Emailinfo@orthofix.it
Phone0456719000
Emailinfo@orthofix.it
Phone0456719000
Emailinfo@orthofix.it

Device Identifiers

Device Issuing AgencyDevice ID
GS118052469476086 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JDWPin, Fixation, Threaded

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2025-06-17
Device Publish Date2022-12-27

On-Brand Devices [MINI-FIXATION SYSTEMS]

18052469476406CALCFIX PLUS CALCANEAL FIXATOR SET STERILE
18052469476086CALCFIX PLUS CALCANEAL FIXATOR STERILE
18052469476055CALCFIX PLUS CALCANEAL FIXATOR

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