Prefix Fixator 99-92503US

GUDID 18033509856167

US PREFIX II DIAPHYSEAL COMPLETE KIT STERILE LONG SCREWS

ORTHOFIX SRL

External orthopaedic fixation system, single-use, sterile

• Primary Device ID: 18033509856167
• NIH Device Record Key: 35b1217a-3cab-474b-83b6-c68b8682b8d1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Prefix Fixator
• Version Model Number: 1
• Catalog Number: 99-92503US
• Company DUNS: 438793622
• Company Name: ORTHOFIX SRL
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	18033509856167 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K955848

FDA Product Code

• JDW: Pin, Fixation, Threaded

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 [Prefix Fixator]

• 18054242511403: JP PREFIX II DIAPHYSEAL COMPLETE KIT STERILE SHORT SCREWS
• 18033509856518: COMPLETE PREFIX II KIT
• 18033509856174: US PREFIX II ANKLE COMPLETE KIT STERILE
• 18033509856167: US PREFIX II DIAPHYSEAL COMPLETE KIT STERILE LONG SCREWS
• 18033509856150: US PREFIX II DIAPHYSEAL COMPLETE KIT STERILE NO SCREWS
• 18033509856143: US PREFIX II DIAPHYSEAL COMPLETE KIT STERILE SHORT SCREWS
• 18033509855979: PREFIX II ANKLE COMPLETE KIT STERILE
• 18033509855962: PREFIX II DIAPHYSEAL COMPLETE KIT STERILE LONG SCREWS
• 18033509855955: PREFIX II DIAPHYSEAL COMPLETE KIT STERILE NO SCREWS
• 18033509855948: PREFIX II DIAPHYSEAL COMPLETE KIT STERILE SHORT SCREWS
• 18033509851780: TRANSFIXING PIN, THREAD L 80 MM STERILE SHAFT D 4MM, THREAD D 5MM
• 18033509851773: TRANSFIXING PIN, THREAD L 50 MM STERILE SHAFT D 4MM, THREAD D 5MM
• 18032937168873: ROD 900 MM LONG
• 18032937168866: ROD 800 MM LONG
• 18032568869286: PIN GUIDE
• 18032568869279: MULTI SCREW CLAMP GUIDE
• 18032568869262: MULTI SCREW CLAMP
• 18032568868678: ROD 500 MM LONG
• 18032568868661: ROD 400 MM LONG
• 18032568867503: TRANSFIXING PIN, THREAD L 50 MM SHAFT D 4MM, THREAD D 5MM
• 18032568867480: TRANSFIXING PIN CLAMP
• 18032568867305: PREFIX STERIBOX, EMPTY
• 18032568867237: SCREW CLIP CLAMP
• 18032568867220: ROD CLIP CLAMP
• 18032568866568: ROD 600 MM LONG
• 18032568866186: ROD 350 MM LONG
• 18032568866179: ROD 275 MM LONG
• 18032568866162: ROD 175 MM LONG
• 18032568866155: ROD 125 MM LONG
• 18053504369899: Spare part, not medical device, not for sale. Reported for registration of UDI direct marking.