ADVANCED LIMB RECONSTRUCTION SYSTEM 530556

GUDID 18053504366072

Spare part, not medical device, not for sale. Reported for registration of UDI direct marking.

ORTHOFIX SRL

External orthopaedic fixation system, reusable

• Primary Device ID: 18053504366072
• NIH Device Record Key: 14d1f315-60d5-4dae-ac63-fa397ec251f2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ADVANCED LIMB RECONSTRUCTION SYSTEM
• Version Model Number: 1
• Catalog Number: 530556
• 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: +0390456719000
• Email: info@orthofix.it
• Phone: +0390456719000
• Email: info@orthofix.it
• Phone: +0390456719000
• Email: info@orthofix.it
• Phone: +0390456719000
• Email: info@orthofix.it
• Phone: +0390456719000
• Email: info@orthofix.it
• Phone: +0390456719000
• Email: info@orthofix.it
• Phone: +0390456719000
• Email: info@orthofix.it
• Phone: +0390456719000
• Email: info@orthofix.it
• Phone: +0390456719000
• Email: info@orthofix.it
• Phone: +0390456719000
• Email: info@orthofix.it
• Phone: +0390456719000
• Email: info@orthofix.it
• Phone: +0390456719000
• Email: info@orthofix.it
• Phone: +0390456719000
• Email: info@orthofix.it
• Phone: +0390456719000
• Email: info@orthofix.it

Device Identifiers

Device Issuing Agency	Device ID
GS1	18053504366072 [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

[18053504366072]

Moist Heat or Steam Sterilization

[18053504366072]

Moist Heat or Steam Sterilization

[18053504366072]

Moist Heat or Steam Sterilization

[18053504366072]

Moist Heat or Steam Sterilization

[18053504366072]

Moist Heat or Steam Sterilization

[18053504366072]

Moist Heat or Steam Sterilization

[18053504366072]

Moist Heat or Steam Sterilization

[18053504366072]

Moist Heat or Steam Sterilization

[18053504366072]

Moist Heat or Steam Sterilization

[18053504366072]

Moist Heat or Steam Sterilization

[18053504366072]

Moist Heat or Steam Sterilization

[18053504366072]

Moist Heat or Steam Sterilization

[18053504366072]

Moist Heat or Steam Sterilization

[18053504366072]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-04-29
• Device Publish Date: 2019-04-19

On-Brand Devices [ADVANCED LIMB RECONSTRUCTION SYSTEM ]

• 18054242510215: ADV SMALL STRAIGHT CLAMP
• 18033509859199: ALLEN HEAD BOLT FOR LRS ADV SYSTEM (PACK OF 25)
• 18033509858260: ADULT LRS ADV HINGE CONNECTION
• 18033509858154: KNEE HINGE CENTERING TEMPLATE
• 18033509858147: CLAMP LOCKING SCREW (PACK OF 5 OF EACH)
• 18033509858123: ADV RADIOLUCENT LRS RAIL 600 MM
• 18033509858116: ADV RADIOLUCENT LRS RAIL 500 MM
• 18033509858109: CLAMP LOCKING SCREW
• 18033509858086: CLAMP SCREW (PACK OF 5 OF EACH)
• 18033509858079: KNEE HINGE REPLACEMENT KIT
• 18033509856594: ADV LRS SANDWICH CLAMP, HEIGHT: 8 MM
• 18033509856587: ADV LRS SANDWICH CLAMP, HEIGHT: 15 MM
• 18033509856181: ADV LRS RAIL 500MM
• 18033509856020: ADV ACUTE DEROTATION ARC 100 MM
• 18033509855986: ADV LRS INSTRUMENTS STERI-BOX EMPTY
• 18033509855887: ADV RADIOLUCENT LRS RAIL 400MM
• 18033509855870: ADV RADIOLUCENT LRS RAIL 350MM
• 18033509855863: ADV RADIOLUCENT LRS RAIL 300MM
• 18033509855856: ADV RADIOLUCENT LRS RAIL 250MM
• 18033509855849: ADV RADIOLUCENT LRS RAIL 200MM
• 18033509855832: ADV RADIOLUCENT LRS RAIL 120MM
• 18033509855825: ADV RADIOLUCENT LRS KIT 200MM
• 18033509855818: ADV RADIOLUCENT LRS KIT 400MM
• 18033509855801: ADV RADIOLUCENT LRS KIT 300MM
• 18033509855795: ADV LRS COMPONENTS STERI-BOX EMPTY B
• 18033509855788: ADV LRS COMPONENTS STERI-BOX EMPTY A
• 18033509855771: KNEE HINGE
• 18033509855764: ADV MULTIPLANAR CLAMP
• 18033509855757: ADV LRS RAIL 350MM
• 18033509855740: ADV BALL-JOINT COUPLING
• 18033509855733: ADV DYNA-RING
• 18033509855726: ADV LRS KIT 200MM
• 18033509855719: ADV LRS KIT 400MM
• 18033509855702: ADV LRS KIT 300MM
• 18033509855696: ADV MICROMETRIC SWIVELLING CLAMP
• 18033509855689: ADV TRUELOK KIT FOR RING CONNECTION
• 18033509855672: ADV GARCHES CD UNIT LONG EXTENDS 10CM
• 18033509855665: ADV GARCHES CD UNIT STANDARD EXTENDS 5,5 CM
• 18033509855658: ADV ACUTE CORRECTION T-TEMPLATE
• 18033509855641: ADV ACUTE CORRECTION STRAIGHT TEMPLATE
• 18033509855634: ADV ACUTE CORRECTION GARCHES TEMPLATE
• 18033509855627: ADV ACUTE DEROTATION TEMPLATE
• 18032568039955: ADV LRS RAIL 120MM
• 18032568039948: ADV LRS RAIL 200MM
• 18032568039931: ADV LRS RAIL 250MM
• 18032568039924: ADV LRS RAIL 300MM
• 18032568039917: ADV LRS RAIL 400MM
• 18032568039900: ADV STRAIGHT CLAMP
• 18032568039894: ADV MICROMETRIC TRANSLATION-ANGULATION CLAMP
• 18032568039887: ADV T GARCHES CLAMP