CHIMAERA Hip Fracture System 99-T932280L

GUDID 18054242514305

CHIMAERA HFS LONG NAIL LEFT 125° L280MM D11MM STERILE

ORTHOFIX SRL

Femur nail, sterile Femur nail, sterile Femur nail Femur nail Femur nail Femur nail Femur nail Femur nail Femur nail Femur nail

• Primary Device ID: 18054242514305
• NIH Device Record Key: a97e1360-0872-4f0a-813b-46975f3fa0fa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CHIMAERA Hip Fracture System
• Version Model Number: 1
• Catalog Number: 99-T932280L
• 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: +390456719000
• Email: info@orthofix.it
• Phone: +390456719000
• Email: info@orthofix.it
• Phone: +390456719000
• Email: info@orthofix.it
• Phone: +390456719000
• Email: info@orthofix.it
• Phone: +390456719000
• Email: info@orthofix.it
• Phone: +390456719000
• Email: info@orthofix.it
• Phone: +390456719000
• Email: info@orthofix.it
• Phone: +390456719000
• Email: info@orthofix.it
• Phone: +390456719000
• Email: info@orthofix.it
• Phone: +390456719000
• Email: info@orthofix.it

Device Identifiers

Device Issuing Agency	Device ID
GS1	18054242514305 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161466

FDA Product Code

• HSB: Rod, Fixation, Intramedullary And Accessories

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: 2017-05-18

On-Brand Devices [CHIMAERA Hip Fracture System]

• 18056099649353: EXTRACTION INSTRUMENT TRAY EMPTY
• 18056099649346: EXTRACTION INSTRUMENT TRAY COMPLETE
• 18056099649339: SUPPLEMENTARY SCREWDRIVER RETENTION ROD - SHORT
• 18056099649322: 6MM HEX EXTENSION
• 18056099649315: IMPLANT TEMPLATE
• 18056099649308: WIRE PUSHER
• 18056099649292: HJ QUICK CONNECT T HANDLE
• 18056099649285: DISTAL SCREW SIZING GAUGE
• 18056099649278: DISTAL TISSUE GUIDE - SHORT
• 18056099649261: LONG NAIL RULER
• 18056099649254: DISTAL SCREWDRIVER RETENTION ROD - SHORT
• 18056099649247: DISTAL SCREWDRIVER - SHORT
• 18056099649230: 4.2MM DISTAL DRILL BIT - SHORT
• 18056099649223: LAG SCREWDRIVER RETENTION ROD - SHORT
• 18056099649216: SCREW EXTRACTOR SIZE 4 - 9MM
• 18056099649209: M8 CONICAL MALLET ADAPTOR
• 18054242515715: CHIMAERA INSTRUMENT TRAY, COMPLETE
• 18054242515708: CHIMAERA INSTRUMENT TRAY, EMPTY
• 18054242515692: 4MM CORTICAL DRILL
• 18054242515685: THREADED GUIDE WIRE L400MM D3.2MM STERILE
• 18054242515678: SUPPLEMENTARY GRADUAL DRILL BIT
• 18054242515661: LAG SCREW GRADUAL REAMER
• 18054242515654: SUPPLEMENTARY SCREWDRIVER
• 18054242515647: LAG SCREW COMPRESSION ROD
• 18054242515630: 4.2MM DISTAL DRILL BIT - LONG
• 18054242515623: SUPPLEMENTARY SCREWDRIVER RETENTION ROD
• 18054242515616: LAG SCREWDRIVER RETENTION ROD
• 18054242515609: LAG SCREWDRIVER
• 18054242515593: TARGETING HANDLE
• 18054242515586: SCREW SIZING GAUGE
• 18054242515579: 6MM HEX SCREWDRIVER
• 18054242515562: LAG SCREW TROCAR
• 18054242515555: LAG SCREW TISSUE GUIDE
• 18054242515548: SUPPLEMENTARY TISSUE GUIDE
• 18054242515531: SUPPLEMENTARY SCREW TROCAR
• 18054242515524: DISTAL TROCAR
• 18054242515517: DISTAL TISSUE GUIDE
• 18054242515500: DISTAL SCREWDRIVER RETENTION ROD
• 18054242515494: DISTAL SCREWDRIVER
• 18054242515487: MULTI HOLE WIRE GUIDE
• 18054242515470: ENTRY REAMER GUIDE
• 18054242515463: CANNULATED AWL
• 18054242515456: ENTRY REAMER
• 18054242515449: SIZING GUIDE
• 18054242515432: LOCKING BOLT
• 18054242515425: IMPACTION ROD
• 18054242515418: CHIMAERA HFS THREADED LOCKING SCREW L90MM THREAD D5MM STERILE
• 18054242515401: CHIMAERA HFS THREADED LOCKING SCREW L85MM THREAD D5MM STERILE
• 18054242515395: CHIMAERA HFS THREADED LOCKING SCREW L80MM THREAD D5MM STERILE
• 18054242515388: CHIMAERA HFS THREADED LOCKING SCREW L75MM THREAD D5MM STERILE