Galaxy Fixation System 99-939300

GUDID 18033509859748

ROD D 9 MM L 300 MM STERILE

ORTHOFIX SRL

External orthopaedic fixation system, single-use, sterile

• Primary Device ID: 18033509859748
• NIH Device Record Key: bdaa2e22-47c2-426d-ae56-91bc1fcd167a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Galaxy Fixation System
• Version Model Number: 1
• Catalog Number: 99-939300
• 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: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• 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: +039456719000
• Email: info@orthofix.it
• Phone: +039456719000
• Email: info@orthofix.it
• Phone: +039456719000
• Email: info@orthofix.it
• Phone: +039456719000
• Email: info@orthofix.it
• Phone: +039456719000
• Email: info@orthofix.it
• Phone: +039456719000
• Email: info@orthofix.it
• Phone: +039456719000
• Email: info@orthofix.it
• Phone: +039456719000
• Email: info@orthofix.it
• Phone: +039456719000
• Email: info@orthofix.it
• Phone: +039456719000
• Email: info@orthofix.it
• Phone: +039456719000
• Email: info@orthofix.it
• Phone: +039456719000
• Email: info@orthofix.it
• Phone: +039456719000
• Email: info@orthofix.it
• Phone: +039456719000
• Email: info@orthofix.it
• Phone: +039456719000
• Email: info@orthofix.it
• Phone: +039456719000
• Email: info@orthofix.it
• Phone: +039456719000
• Email: info@orthofix.it
• Phone: +039456719000
• Email: info@orthofix.it
• Phone: +039456719000
• Email: info@orthofix.it
• Phone: +039456719000
• Email: info@orthofix.it
• Phone: +039456719000
• Email: info@orthofix.it
• Phone: +039456719000
• Email: info@orthofix.it
• Phone: +039456719000
• Email: info@orthofix.it
• Phone: +039456719000
• Email: info@orthofix.it
• Phone: +039456719000
• Email: info@orthofix.it
• Phone: +039456719000
• Email: info@orthofix.it
• Phone: +039456719000
• Email: info@orthofix.it
• Phone: +039456719000
• Email: info@orthofix.it
• Phone: +039456719000
• Email: info@orthofix.it
• Phone: +039456719000
• Email: info@orthofix.it
• Phone: +039456719000
• Email: info@orthofix.it

Device Dimensions

• Length: 300 Millimeter
• Outer Diameter: 9 Millimeter
• Length: 300 Millimeter
• Outer Diameter: 9 Millimeter
• Length: 300 Millimeter
• Outer Diameter: 9 Millimeter
• Length: 300 Millimeter
• Outer Diameter: 9 Millimeter
• Length: 300 Millimeter
• Outer Diameter: 9 Millimeter
• Length: 300 Millimeter
• Outer Diameter: 9 Millimeter
• Length: 300 Millimeter
• Outer Diameter: 9 Millimeter
• Length: 300 Millimeter
• Outer Diameter: 9 Millimeter
• Length: 300 Millimeter
• Outer Diameter: 9 Millimeter
• Length: 300 Millimeter
• Outer Diameter: 9 Millimeter
• Length: 300 Millimeter
• Outer Diameter: 9 Millimeter
• Length: 300 Millimeter
• Outer Diameter: 9 Millimeter
• Length: 300 Millimeter
• Outer Diameter: 9 Millimeter
• Length: 300 Millimeter
• Outer Diameter: 9 Millimeter
• Length: 300 Millimeter
• Outer Diameter: 9 Millimeter
• Length: 300 Millimeter
• Outer Diameter: 9 Millimeter
• Length: 300 Millimeter
• Outer Diameter: 9 Millimeter
• Length: 300 Millimeter
• Outer Diameter: 9 Millimeter
• Length: 300 Millimeter
• Outer Diameter: 9 Millimeter
• Length: 300 Millimeter
• Outer Diameter: 9 Millimeter
• Length: 300 Millimeter
• Outer Diameter: 9 Millimeter
• Length: 300 Millimeter
• Outer Diameter: 9 Millimeter
• Length: 300 Millimeter
• Outer Diameter: 9 Millimeter
• Length: 300 Millimeter
• Outer Diameter: 9 Millimeter
• Length: 300 Millimeter
• Outer Diameter: 9 Millimeter
• Length: 300 Millimeter
• Outer Diameter: 9 Millimeter
• Length: 300 Millimeter
• Outer Diameter: 9 Millimeter
• Length: 300 Millimeter
• Outer Diameter: 9 Millimeter
• Length: 300 Millimeter
• Outer Diameter: 9 Millimeter
• Length: 300 Millimeter
• Outer Diameter: 9 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	18033509859748 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K113770

FDA Product Code

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

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-09-01

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