MINI-FIXATION SYSTEMS M146

GUDID 18052469476055

CALCFIX PLUS CALCANEAL FIXATOR

ORTHOFIX SRL

External orthopaedic fixation system, reusable

• Primary Device ID: 18052469476055
• NIH Device Record Key: ccb663ee-4816-46e7-b3b6-fe8a803d84b3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MINI-FIXATION SYSTEMS
• Version Model Number: 1
• Catalog Number: M146
• Company DUNS: 438793622
• Company Name: ORTHOFIX SRL
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 0456719000
• Email: info@orthofix.it
• Phone: 0456719000
• Email: info@orthofix.it
• Phone: 0456719000
• Email: info@orthofix.it
• Phone: 0456719000
• Email: info@orthofix.it
• Phone: 0456719000
• Email: info@orthofix.it
• Phone: 0456719000
• Email: info@orthofix.it
• Phone: 0456719000
• Email: info@orthofix.it
• Phone: 0456719000
• Email: info@orthofix.it
• Phone: 0456719000
• Email: info@orthofix.it
• Phone: 0456719000
• Email: info@orthofix.it
• Phone: 0456719000
• Email: info@orthofix.it
• Phone: 0456719000
• Email: info@orthofix.it
• Phone: 0456719000
• Email: info@orthofix.it

Device Identifiers

Device Issuing Agency	Device ID
GS1	18052469476055 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K955848

FDA Product Code

• JDW: Pin, Fixation, Threaded

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[18052469476055]

Moist Heat or Steam Sterilization

[18052469476055]

Moist Heat or Steam Sterilization

[18052469476055]

Moist Heat or Steam Sterilization

[18052469476055]

Moist Heat or Steam Sterilization

[18052469476055]

Moist Heat or Steam Sterilization

[18052469476055]

Moist Heat or Steam Sterilization

[18052469476055]

Moist Heat or Steam Sterilization

[18052469476055]

Moist Heat or Steam Sterilization

[18052469476055]

Moist Heat or Steam Sterilization

[18052469476055]

Moist Heat or Steam Sterilization

[18052469476055]

Moist Heat or Steam Sterilization

[18052469476055]

Moist Heat or Steam Sterilization

[18052469476055]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2025-06-17
• Device Publish Date: 2022-12-27

On-Brand Devices [MINI-FIXATION SYSTEMS]

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