PELVIC FIXATOR 10083

GUDID 18032568030839

PELVIC FIXATOR LONG KIT WITH INDEP.SCREW PLACEMENT MODULES

ORTHOFIX SRL

External orthopaedic fixation system, reusable

• Primary Device ID: 18032568030839
• NIH Device Record Key: bb38deec-f641-4ab3-be34-646375126af1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PELVIC FIXATOR
• Version Model Number: 1
• Catalog Number: 10083
• 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
• Phone: +0390456719000
• Email: info@orthofix.it

Device Identifiers

Device Issuing Agency	Device ID
GS1	18032568030839 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K955848

FDA Product Code

• JDW: Pin, Fixation, Threaded

Sterilization

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

[18032568030839]

Moist Heat or Steam Sterilization

[18032568030839]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-04-06

On-Brand Devices [PELVIC FIXATOR]

• 18032568032833: PELVIC FIXATOR STERI BOX EMPTY
• 18032568030884: CONNECTING UNIT FOR PELVIC FIXATOR
• 18032568030877: SUPPLEMENTARY LINK FOR PELVIC FIXATOR
• 18032568030860: PRIMARY LINK
• 18032568030853: PELVIC FIXATOR SHORT BODY
• 18032568030846: PELVIC FIXATOR LONG BODY
• 18032568030839: PELVIC FIXATOR LONG KIT WITH INDEP.SCREW PLACEMENT MODULES
• 18032568030822: PELVIC FIXATOR SHORT MODEL KIT
• 18032568030815: PELVIC FIXATOR LONG MODEL KIT
• 18032568030655: INDEPENDENT SCREW CLAMP
• 18032568030648: BALL-JOINTED MODULE FOR INDEPENDENT SCREW PLACEMENT
• 18053504364856: Component. Not for sale. Used for reporting Direct Marking of assembly.
• 18053504364832: Component. Not for sale. Used for reporting Direct Marking of assembly.