ORTHOFIX 99-60003626

GUDID 18059015370980

FITBONE TRANSPORT LENGTHENING TRIAL NAIL TLN 1180-T-40-470 STERILE

ORTHOFIX SRL

Bone nail trial, single-use

• Primary Device ID: 18059015370980
• NIH Device Record Key: 3057047a-efbf-4269-a2c9-b9c2e331f4e2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ORTHOFIX
• Version Model Number: 1
• Catalog Number: 99-60003626
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• 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

Device Dimensions

• Length: 470 Millimeter
• Outer Diameter: 11 Millimeter
• Length: 470 Millimeter
• Outer Diameter: 11 Millimeter
• Length: 470 Millimeter
• Outer Diameter: 11 Millimeter
• Length: 470 Millimeter
• Outer Diameter: 11 Millimeter
• Length: 470 Millimeter
• Outer Diameter: 11 Millimeter
• Length: 470 Millimeter
• Outer Diameter: 11 Millimeter
• Length: 470 Millimeter
• Outer Diameter: 11 Millimeter
• Length: 470 Millimeter
• Outer Diameter: 11 Millimeter
• Length: 470 Millimeter
• Outer Diameter: 11 Millimeter
• Length: 470 Millimeter
• Outer Diameter: 11 Millimeter
• Length: 470 Millimeter
• Outer Diameter: 11 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	18059015370980 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K232169

FDA Product Code

• HSB: Rod, Fixation, Intramedullary And Accessories

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-05-01
• Device Publish Date: 2024-04-23

On-Brand Devices [ORTHOFIX]

• 18053800898710: JPS MODULAR TRAY LID
• 18053800898703: JPS MODULAR BASE 5.0MM INSTRUMENT
• 18053800898697: JPS MODULAR BASE 3.5MM INSTRUMENT
• 18053800898680: JPS MODULAR BASE 3.0MM INSTRUMENT
• 18053800898673: JPS MODULAR BASE GENERAL INSTRUMENT
• 18053800898666: JPS MUDULAR TRAY COMPLETE
• 18053800898543: SS MEDIALIZATION GUIDE BODY 5.0MM
• 18053800898536: SS MEDIALIZATION GUIDE BODY 3.5MM
• 18053800898529: SS MEDIALIZATION GUIDE MECHANISM
• 18053800898512: SS LARGE BONE CLAMP
• 18053800898505: SS SMALL BONE CLAMP
• 18053800898499: AL DOUBLE MEASURING DEVICE
• 18053800898482: SS OSTEOTOMY GAUGE
• 18053800898475: AL ANGLED WIRE GUIDE 3.0MM PLATE
• 18053800898468: SS AIMING BLOCK 3.5MM PLATE
• 18053800898451: SS AIMING BLOCK 5.0MM PLATE
• 18053800898444: ALANGLED WIRE GUIDE 3.5 AND 5.0MM PLATES
• 18053800898437: SS TRIANGULAR POSITIONING PLATE 90° 50° 40°
• 18053800898420: SS TRIANGULAR POSITIONING PLATE 70° 80° 30°
• 18053800898413: SS TRIANGULAR POSITIONING PLATE 60° 100° 20°
• 18053800898376: SS T15 RETENTIVE SCREWDRIVER QUICK CONNECT
• 18053800898369: SS T10 RETENTIVE SCREWDRIVER QUICK CONNECT
• 18053800898352: SS T8 RETENTIVE SCREWDRIVER QUICK CONNECT
• 18053800898345: SS DRILL GUIDE NON LOCKING D3.4MM
• 18053800898338: SS DRILL GUIDE NON LOCKING D2.8MM
• 18053800898321: SS DRILL GUIDE NON LOCKING D2.3MM
• 18053800898314: SS DRILL BIT D4.3MM QUICK CONNECT
• 18053800898307: SS DRILL BIT D3.4MM QUICK CONNECT
• 18053800898291: SS DRILL BIT D2.8MM QUICK CONNECT
• 18053800898284: SS DRILL BIT D2.3MM QUICK CONNECT
• 18053800898277: SS REDUCTION SLEEVE
• 18053800898260: SS DRILL GUIDE LOCKING D4.3MM
• 18053800898253: SS DRILL GUIDE LOCKING D2.8MM
• 18053800898246: SS DRILL GUIDE LOCKING D2.3MM
• 18053800898192: SS GUIDE WIRE D2.0MM L200MM PACK OF 2
• 18053340340434: SS JPS TEMPLATE
• 18053800898604: SS T15 EXTRACTION SCREWDRIVER
• 18053800898598: SS T10 EXTRACTION SCREWDRIVER
• 18053800898581: SS T8 EXTRACTION SCREWDRIVER
• 18053800898567: SS T10-T15 CONICAL EXTRACTOR
• 18053800898550: SS T8 CONICAL EXTRACTOR
• 18053800898239: SS GUIDE WIRE D4.3MM L190MM PACK OF 2
• 18053800898222: SS GUIDE WIRE D3.4MM L200MM PACK OF 2
• 18053800898215: SS GUIDE WIRE D2.8MM L200MM PACK OF 2
• 18059015372939: G-BEAM SIZING GAUGE
• 18033509857898: SMN SYSTEM SLIDING HAMMER ASSEMBLY
• 18052469475966: 1
• 18059015370553: FITBONE TRANSPORT NAIL TN 1340-F-R-490 STERILE
• 18059015370546: FITBONE TRANSPORT NAIL TN 1340-F-R-470 STERILE
• 18059015370539: FITBONE TRANSPORT NAIL TN 1340-F-R-450 STERILE