ELBOW FIXATOR 10070

GUDID 18032568030709

ELBOW FIXATOR WITH PROCALLUS STRAIGHT CLAMPS

ORTHOFIX SRL

External orthopaedic fixation system, reusable External orthopaedic fixation system, reusable

• Primary Device ID: 18032568030709
• NIH Device Record Key: 521ca461-6f28-42f3-8330-d4e46e460915
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ELBOW FIXATOR
• Version Model Number: 1
• Catalog Number: 10070
• 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	18032568030709 [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

[18032568030709]

Moist Heat or Steam Sterilization

[18032568030709]

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 [ELBOW FIXATOR]

• 18032568032840: ELBOW FIXATOR STERI BOX EMPTY
• 18032568032536: X-WIRE WITHOUT OLIVE DIAMETER 2 MM LENGTH 150 MM
• 18032568030785: SHORT PRIMARY LINK
• 18032568030778: CD UNIT SPACERS (1 PAIR) FOR ELBOW FIXATOR
• 18032568030747: ELBOW FIXATOR CENTRAL BODY
• 18032568030730: LINK LOCKING SCREW FOR ELBOW FIXATOR
• 18032568030723: SMALL DISTRACTOR FOR ELBOW FIXATOR
• 18032568030716: CENTRAL CONNECTING UNIT FOR ELBOW FIXATOR
• 18032568030709: ELBOW FIXATOR WITH PROCALLUS STRAIGHT CLAMPS
• 18053504365679: Component. Not for sale. Used for reporting Direct Marking of assembly.
• 18053504364825: Component. Not for sale. Used for reporting Direct Marking of assembly.
• 18053504364818: Component. Not for sale. Used for reporting Direct Marking of assembly.
• 18053504364801: Component. Not for sale. Used for reporting Direct Marking of assembly.
• 18053504364795: Component. Not for sale. Used for reporting Direct Marking of assembly.
• 18032568868739: Component. Not for sale. Used for reporting Direct Marking of assembly.