GALAXY FIXATION SYSTEM 93350

GUDID 18054242511618

WRIST MODULE

ORTHOFIX SRL

External orthopaedic fixation system, reusable External orthopaedic fixation system, reusable

• Primary Device ID: 18054242511618
• NIH Device Record Key: 1f1002bb-3602-4fa5-bcd2-70c844411dc3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GALAXY FIXATION SYSTEM
• Version Model Number: 1
• Catalog Number: 93350
• Company DUNS: 438793622
• Company Name: ORTHOFIX SRL
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	18054242511618 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141760

FDA Product Code

• KTT: Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component

Sterilization

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

[18054242511618]

Moist Heat or Steam Sterilization

[18054242511618]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-09-17
• Device Publish Date: 2018-04-24

On-Brand Devices [GALAXY FIXATION SYSTEM]

• 18054242518969: GALAXY TL-HEX CONNECTING POST L100MM D12MM STERILE
• 18054242518952: GALAXY TL-HEX CONNECTING POST L100MM D 12MM
• 18054242518945: GALAXY TL-HEX CONNECTING POST L50MM D12MM STERILE
• 18054242518938: GALAXY TL-HEX CONNECTING POST L50MM D 12MM
• 18054242518716: GALAXY MEDIUM - PAEDIATRIC STERILE KIT - SCREW THREAD D4MM
• 18054242518709: GALAXY MEDIUM - PAEDIATRIC STERILE KIT - SCREW THREAD D5MM
• 18054242518693: GALAXY FIXATION SYSTEM SEMICIRCULAR ROD D12MM L250MM LARGE STERILE
• 18054242518686: GALAXY FIXATION SYSTEM SEMICIRCULAR ROD D12MM L215MM MEDIUM STERILE
• 18054242518679: GALAXY FIXATION SYSTEM SEMICIRCULAR ROD D12MM L180MM SMALL STERILE
• 18054242515203: GALAXY ANKLE BRIDGING DELTA FRAME STERILE KIT
• 18054242515197: GALAXY SMALL SPANNING 'Z' FRAME STERILE KIT
• 18054242511670: SMALL MULTISCREW CLAMP-SHORT STERILE
• 18054242511663: SMALL MULTISCREW CLAMP-LONG STERILE
• 18054242511656: Galaxy Wrist Sterile Kit
• 18054242511649: SCREW GUIDE
• 18054242511632: T-WRENCH 4MM SHAFT
• 18054242511625: 6 MM L ROD
• 18054242511618: WRIST MODULE
• 18054242511601: SMALL MULTISCREW CLAMP-SHORT
• 18054242511595: SMALL MULTISCREW CLAMP-LONG
• 18054242511588: GALAXY WRIST TRAY EMPTY
• 18054242511540: SHOULDER STERILE KIT
• 18054242511533: ELBOW STERILE KIT
• 18054242511526: MEDIUM MULTISCREW CLAMP STERILE
• 18054242511519: LARGE-MEDIUM TRANSITION CLAMP STERILE
• 18054242511502: SEMI CIRCULAR ROD D 9 MM LARGE
• 18054242511496: SEMI CIRCULAR ROD D 9 MM MEDIUM
• 18054242511489: SEMI CIRCULAR ROD D 9 MM SMALL
• 18054242511472: MEDIUM MULTISCREW CLAMP
• 18054242511465: LARGE-MEDIUM TRANSITION CLAMP
• 18054242511397: TRANSFIX PIN 80 MM QC
• 18054242511380: TRANSFIX PIN 50 MM QC
• 18054242511328: GALAXY ELBOW EMPTY TRAY
• 18054242511311: GALAXY INSTRUMENTS EMPTY TRAY
• 18054242511304: ANKLE TRANSFIX PIN STERILE KIT
• 18054242511298: TIBIA FEMUR DIAPHYSEAL STERILE KIT
• 18054242511281: PELVIS STERILE KIT
• 18054242510895: LOWER LIMB DIAPHYSEAL STERILE KIT (STERILE GAMMA)
• 18054242510888: PELVIS STERILE KIT (STERILE GAMMA)
• 18054242510833: KIT FISSATORE GALAXY PER SPALLA
• 18054242510147: DISTRACTOR CAM
• 18054242510130: GALAXY SHOULDER EMPTY TRAY
• 18054242510123: GALAXY ELBOW EMPTY TRAY
• 18054242510116: GALAXY LOWER EMPTY TRAY
• 18054242510109: GALAXY UPPER EMPTY TRAY
• 18054242510093: GALAXY UPPER+INSTRUMENTS EMPTY TRAY
• 18054242510086: GALAXY LOWER+INSTRUMENTS EMPTY TRAY
• 18054242510079: GALAXY INSTRUMENTS EMPTY TRAY
• 18054242510062: GALAXY UPPER+LOWER EMPTY TRAY
• 18054242510055: WIRE BENDER