HYBRID FIXATOR SYSTEM 800035

GUDID 18053504366188

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: 18053504366188
• NIH Device Record Key: f90912c7-1155-460b-a10e-d857785b635a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HYBRID FIXATOR SYSTEM
• Version Model Number: 1
• Catalog Number: 800035
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	18053504366188 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K944092

FDA Product Code

• JEC: Component, Traction, Invasive

Sterilization

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

[18053504366188]

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 [HYBRID FIXATOR SYSTEM]

• 18033509851766: X-WIRE WITHOUT OLIVE STERILE DIAMETER 1,8 MM LENGTH 400 MM
• 18033509851759: X-WIRE WITH CENTRAL OLIVE STERILE DIAMETER 1,8 MM LENGTH 400 MM
• 18033509851742: X-WIRE WITHOUT OLIVE STERILE DIAMETER 2 MM LENGTH 450 MM
• 18033509851735: X-WIRE WITH CENTRAL OLIVE STERILE DIAMETER 2 MM LENGTH 450 MM
• 18033509851728: X-WIRE WITHOUT OLIVE STERILE DIAMETER 2 MM LENGTH 400 MM
• 18033509851711: X-WIRE WITH CENTRAL OLIVE STERILE DIAMETER 2 MM LENGTH 400 MM
• 18033509851704: X-WIRE WITH LATERAL OLIVE STERILE DIAMETER 2 MM LENGTH 400 MM
• 18033509851698: X-WIRE WITH LATERAL OLIVE STERILE DIAMETER 2 MM LENGTH 350 MM
• 18033509851681: X-WIRE WITH LATERAL OLIVE STERILE DIAMETER 2 MM LENGTH 310 MM
• 18032568869217: X-WIRE WITHOUT OLIVE DIAMETER 1,8 MM LENGTH 400 MM
• 18032568869200: X-WIRE WITH CENTRAL OLIVE DIAMETER 1,8 MM LENGTH 400 MM
• 18032568860955: HYBRID SYSTEM STERI BOX EMPTY
• 18032568860948: HYBRID SYSTEM STERI BOX EMPTY
• 18032568860832: SUPPLEMENTARY SCREW HOLDER BAR RADIOLUCENT 300 MM
• 18032568860597: WIRE COVERS (PACK OF 20)
• 18032568860580: X-WIRE WITHOUT OLIVE DIAMETER 2 MM LENGTH 450 MM
• 18032568860573: X-WIRE WITH CENTRAL OLIVE DIAMETER 2 MM LENGTH 450 MM
• 18032568860566: X-WIRE WITHOUT OLIVE DIAMETER 2 MM LENGTH 400 MM
• 18032568860559: X-WIRE WITH CENTRAL OLIVE DIAMETER 2 MM LENGTH 400 MM
• 18032568860542: X-WIRE WITH LATERAL OLIVE DIAMETER 2 MM LENGTH 400 MM
• 18032568860535: X-WIRE WITH LATERAL OLIVE DIAMETER 2 MM LENGTH 350 MM
• 18032568860528: X-WIRE WITH LATERAL OLIVE DIAMETER 2 MM LENGTH 310 MM
• 18032568860474: ASSEMBLY KIT SHORT FOR HYBRID PROCALLUS
• 18032568860467: ASSEMBLY KIT STANDARD FOR HYBRID PROCALLUS
• 18032568860450: HYBRID COUPLING WITH BALL-JOINT
• 18032568860436: POST LENGTH 150 MM
• 18032568860412: POST LENGTH 100 MM
• 18032568860405: SUPPLEMENTARY SCREW HOLDER BAR DIAMETER 6 MM LENGTH 300 MM
• 18032568860399: POST LENGTH 50 MM
• 18032568860382: INDEPENDENT WIRE CLAMP
• 18032568860290: 3-HOLE WIRE CLAMP SLIDER UNIT
• 18032568860276: TWO-HOLE K-WIRE SECURING PIN
• 18032568035193: HYBRID COUPLING TEMPLATE WITH BALL-JOINT (10000 SERIES)
• 18032568035186: WIRE GUIDE
• 18032568035179: WIRE TENSIONER
• 18053504366188: Spare part, not medical device, not for sale. Reported for registration of UDI direct marking.
• 18053504365778: Component. Not for sale. Used for reporting Direct Marking of assembly.