SHEFFIELD RING FIXATOR 810020

GUDID 18053504365907

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: 18053504365907
• NIH Device Record Key: da673dcf-8378-46a4-a5e3-061da015cc23
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SHEFFIELD RING FIXATOR
• Version Model Number: 1
• Catalog Number: 810020
• 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	18053504365907 [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

[18053504365907]

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 [SHEFFIELD RING FIXATOR ]

• 18033509856570: K-WIRE LOSS OF TENSION ESTIMATION ACCESSORY
• 18033509856228: 3-HOLE POST, 90 DEGREES
• 18033509856211: 2-HOLE POST, 90 DEGREES
• 18033509856112: POST CLAMP
• 18033509855412: K-WIRE LOCKING SCREW (PACK OF 2)
• 18032937169610: MAGIC CUBE
• 18032937168071: HALF PIN BOLT
• 18032568867275: HYBRID RINGS STERIBOX, EMPTY
• 18032568866506: 2 HOLE K-WIRE CLAMP
• 18032568866490: 4 HOLE K-WIRE CLAMP
• 18032568866483: K.WIRE CLAMP KIT
• 18032568865714: CHONDRODIATASI HYBRID KIT RING D.150 MM
• 18032568864854: 2/3 RING DIA. 240 MM
• 18032568860979: FOOT RING DIAMETER 150 MM
• 18032568860962: SHEFFIELD RING FIXATION SYSTEM STERI BOX EMPTY
• 18032568860870: 1/3 RING MM 125
• 18032568860863: 2/3 RING INNER DIAMETER 125MM
• 18032568860856: THREADED BARS LENGTH 400MM (SET OF 3)
• 18032568860849: THREADED BARS LENGTH 300MM (SET OF 3)
• 18032568860825: THREADED BARS LENGTH 200MM (SET OF 3)
• 18032568860818: THREADED BARS LENGTH 160MM (SET OF 3)
• 18032568860801: THREADED BARS LENGTH 120MM (SET OF 3)
• 18032568860795: THREADED BARS LENGTH 80MM (SET OF 3)
• 18032568860788: OPEN END WRENCH
• 18032568860771: SPEED WRENCH
• 18032568860764: COUNTER NUT
• 18032568860757: BOLT 25 MM (PACK OF 10)
• 18032568860740: SLOTTED WASHERS (PACK OF 10)
• 18032568860733: NUTS & WASHERS (PACK OF 20)
• 18032568860726: BOLT 35 MM (PACK OF 10)
• 18032568860719: EXTENSION PLATE
• 18032568860702: HINGE CLAMP
• 18032568860696: TRANSLATION ROTATION HINGE
• 18032568860689: RING LOCKING SCREW
• 18032568860672: 1/3 RING INNER DIAMETER 220MM
• 18032568860665: 2/3 RING INNER DIAMETER 220MM
• 18032568860658: 1/3 RING INNER DIAMETER 190MM
• 18032568860641: 2/3 RING INNER DIAMETER 190MM
• 18032568860634: 1/3 RING INNER DIAMETER 175MM
• 18032568860627: 2/3 RING INNER DIAMETER 175MM
• 18032568860610: 1/3 RING INNER DIAMETER 150MM
• 18032568860603: 2/3 RING INNER DIAMETER 150MM
• 18032568860511: 8/10 MM SPANNER
• 18032568860504: SINGLE SCREW CLAMP
• 18032568860443: REDUCTION UNIT
• 18032568860368: THREADED BARS LENGTH 200 MM (SET OF 3)
• 18032568860351: THREADED BARS LENGTH 160 MM (SET OF 3)
• 18032568860344: THREADED BARS LENGTH 120 MM (SET OF 3)
• 18032568860337: THREADED BARS LENGTH 80 MM (SET OF 3)
• 18032568860313: SHEFFIELD CLAMP