FITBONE TAA SYSTEM 60001421

GUDID 18053340343985

FITBONE STEP REAMER TAA1160 OVERSIZE

ORTHOFIX SRL

Medullary canal orthopaedic reamer, rigid

• Primary Device ID: 18053340343985
• NIH Device Record Key: 7c40e01f-632a-4ba9-8b08-5ac88dda29b5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FITBONE TAA SYSTEM
• Version Model Number: 1
• Catalog Number: 60001421
• Company DUNS: 438793622
• Company Name: ORTHOFIX SRL
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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
• Phone: +0390456719000
• Email: info@orthofix.it
• Phone: +0390456719000
• Email: info@orthofix.it
• Phone: +0390456719000
• Email: info@orthofix.it
• Phone: +0390456719000
• Email: info@orthofix.it
• Phone: +0390456719000
• Email: info@orthofix.it
• Phone: +0390456719000
• Email: info@orthofix.it
• Phone: +0390456719000
• Email: info@orthofix.it
• Phone: +0390456719000
• Email: info@orthofix.it
• Phone: +0390456719000
• Email: info@orthofix.it
• Phone: +0390456719000
• Email: info@orthofix.it
• Phone: +0390456719000
• Email: info@orthofix.it
• Phone: +0390456719000
• Email: info@orthofix.it
• Phone: +0390456719000
• Email: info@orthofix.it
• Phone: +0390456719000
• Email: info@orthofix.it
• Phone: +0390456719000
• Email: info@orthofix.it
• Phone: +0390456719000
• Email: info@orthofix.it
• Phone: +0390456719000
• Email: info@orthofix.it
• Phone: +0390456719000
• Email: info@orthofix.it
• Phone: +0390456719000
• Email: info@orthofix.it
• Phone: +0390456719000
• Email: info@orthofix.it
• Phone: +0390456719000
• Email: info@orthofix.it
• Phone: +0390456719000
• Email: info@orthofix.it
• Phone: +0390456719000
• Email: info@orthofix.it
• Phone: +0390456719000
• Email: info@orthofix.it
• Phone: +0390456719000
• Email: info@orthofix.it
• Phone: +0390456719000
• Email: info@orthofix.it
• Phone: +0390456719000
• Email: info@orthofix.it
• Phone: +0390456719000
• Email: info@orthofix.it
• Phone: +0390456719000
• Email: info@orthofix.it

Device Dimensions

• Outer Diameter: 11 Millimeter
• Length: 60 Millimeter
• Outer Diameter: 11 Millimeter
• Length: 60 Millimeter
• Outer Diameter: 11 Millimeter
• Length: 60 Millimeter
• Outer Diameter: 11 Millimeter
• Length: 60 Millimeter
• Outer Diameter: 11 Millimeter
• Length: 60 Millimeter
• Outer Diameter: 11 Millimeter
• Length: 60 Millimeter
• Outer Diameter: 11 Millimeter
• Length: 60 Millimeter
• Outer Diameter: 11 Millimeter
• Length: 60 Millimeter
• Outer Diameter: 11 Millimeter
• Length: 60 Millimeter
• Outer Diameter: 11 Millimeter
• Length: 60 Millimeter
• Outer Diameter: 11 Millimeter
• Length: 60 Millimeter
• Outer Diameter: 11 Millimeter
• Length: 60 Millimeter
• Outer Diameter: 11 Millimeter
• Length: 60 Millimeter
• Outer Diameter: 11 Millimeter
• Length: 60 Millimeter
• Outer Diameter: 11 Millimeter
• Length: 60 Millimeter
• Outer Diameter: 11 Millimeter
• Length: 60 Millimeter
• Outer Diameter: 11 Millimeter
• Length: 60 Millimeter
• Outer Diameter: 11 Millimeter
• Length: 60 Millimeter
• Outer Diameter: 11 Millimeter
• Length: 60 Millimeter
• Outer Diameter: 11 Millimeter
• Length: 60 Millimeter
• Outer Diameter: 11 Millimeter
• Length: 60 Millimeter
• Outer Diameter: 11 Millimeter
• Length: 60 Millimeter
• Outer Diameter: 11 Millimeter
• Length: 60 Millimeter
• Outer Diameter: 11 Millimeter
• Length: 60 Millimeter
• Outer Diameter: 11 Millimeter
• Length: 60 Millimeter
• Outer Diameter: 11 Millimeter
• Length: 60 Millimeter
• Outer Diameter: 11 Millimeter
• Length: 60 Millimeter
• Outer Diameter: 11 Millimeter
• Length: 60 Millimeter
• Outer Diameter: 11 Millimeter
• Length: 60 Millimeter
• Outer Diameter: 11 Millimeter
• Length: 60 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	18053340343985 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K163368

FDA Product Code

• HSB: Rod, Fixation, Intramedullary And Accessories

Sterilization

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

[18053340343985]

Moist Heat or Steam Sterilization

[18053340343985]

Moist Heat or Steam Sterilization

[18053340343985]

Moist Heat or Steam Sterilization

[18053340343985]

Moist Heat or Steam Sterilization

[18053340343985]

Moist Heat or Steam Sterilization

[18053340343985]

Moist Heat or Steam Sterilization

[18053340343985]

Moist Heat or Steam Sterilization

[18053340343985]

Moist Heat or Steam Sterilization

[18053340343985]

Moist Heat or Steam Sterilization

[18053340343985]

Moist Heat or Steam Sterilization

[18053340343985]

Moist Heat or Steam Sterilization

[18053340343985]

Moist Heat or Steam Sterilization

[18053340343985]

Moist Heat or Steam Sterilization

[18053340343985]

Moist Heat or Steam Sterilization

[18053340343985]

Moist Heat or Steam Sterilization

[18053340343985]

Moist Heat or Steam Sterilization

[18053340343985]

Moist Heat or Steam Sterilization

[18053340343985]

Moist Heat or Steam Sterilization

[18053340343985]

Moist Heat or Steam Sterilization

[18053340343985]

Moist Heat or Steam Sterilization

[18053340343985]

Moist Heat or Steam Sterilization

[18053340343985]

Moist Heat or Steam Sterilization

[18053340343985]

Moist Heat or Steam Sterilization

[18053340343985]

Moist Heat or Steam Sterilization

[18053340343985]

Moist Heat or Steam Sterilization

[18053340343985]

Moist Heat or Steam Sterilization

[18053340343985]

Moist Heat or Steam Sterilization

[18053340343985]

Moist Heat or Steam Sterilization

[18053340343985]

Moist Heat or Steam Sterilization

[18053340343985]

Moist Heat or Steam Sterilization

[18053340343985]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-04-20
• Device Publish Date: 2023-04-12

On-Brand Devices [FITBONE TAA SYSTEM]

• 18053340345378: FITBONE DUMMY TAA0940-T-200
• 18053340345361: FITBONE DUMMY TAA0940-F-200
• 18053340344951: FITBONE STEP REAMER TAA0940
• 18053340344906: FITBONE CONE C13 RETROPATELLAR
• 18053340344869: FITBONE DUMMY TAA0960-T-220
• 18053340344852: FITBONE DUMMY TAA0960-F-220
• 18053340344845: FITBONE STEP REAMER TAA0960
• 18053340344838: FITBONE DRILL BIT L300MM D4MM
• 18053340344807: FITBONE LOCKING SCREW SHORT THREAD L35MM D4MM
• 18053340344791: FITBONE LOCKING SCREW SHORT THREAD L30MM D4MM
• 18053340344784: FITBONE LOCKING SCREW SHORT THREAD L25MM D4MM
• 18053340344777: FITBONE LOCKING SCREW SHORT THREAD L20MM D4MM
• 18053340344418: FITBONE DUMMY TAA1380-F-245
• 18053340344227: FITBONE STEP REAMER TAA1140
• 18053340344159: FITBONE DUMMY TAA1180-T-245
• 18053340344050: FITBONE GRID PLATE
• 18053340344005: FITBONE TARGETING DEVICE 45°/90°
• 18053340343985: FITBONE STEP REAMER TAA1160 OVERSIZE
• 18053340343978: FITBONE STEP REAMER TAA1180 OVERSIZE
• 18053340343961: FITBONE STEP REAMER TAA1160
• 18053340343879: FITBONE WIRE CATCHER 90 DEG
• 18053340343831: FITBONE DUMMY TAA1140-F-205
• 18053340343817: FITBONE DUMMY TAA1140-T-205
• 18053340343794: FITBONE DRILL GUIDE BLOCK SCREWS TAA11
• 18053340343787: FITBONE OUTRIGGER TAA
• 18053340343770: FITBONE STEP REAMER TAA1180
• 18053340343763: FITBONE DRILL GUIDE TAA
• 18053340343756: FITBONE DUMMY TAA1160-F-225
• 18053340343732: FITBONE TUBE-SINKER TS14
• 18053340343725: FITBONE TUBE-SINKER TS15
• 18053340343718: FITBONE CONE C14
• 18053340343701: FITBONE CONE C15++
• 18053340343695: FITBONE CONE C15+
• 18053340343688: FITBONE CONE C15
• 18053340343671: FITBONE TUBE T13/12-XL
• 18053340343664: FITBONE TUBE T14/13-XL
• 18053340343657: FITBONE TUBE T15/14-XL
• 18053340343640: FITBONE TUBE T16/15-XL
• 18053340343633: FITBONE TUBE T13/12-L
• 18053340343626: FITBONE TUBE T14/13-L
• 18053340343619: FITBONE TUBE T15/14-L
• 18053340343602: FITBONE TUBE T16/15-L
• 18053340343596: FITBONE TUBE T15/14-M
• 18053340343589: FITBONE TUBE T16/15-M
• 18053340343572: FITBONE TUBE T12/08-S
• 18053340343565: FITBONE TUBE T12/09-S
• 18053340343558: FITBONE TUBE T12/10-S
• 18053340343541: FITBONE TUBE T12/11-S
• 18053340343534: FITBONE TUBE T13/12-S
• 18053340343527: FITBONE TUBE T14/13-S