PRECICE® Trauma Nail System CDT12.5-30T240

GUDID 00812258027520

Orthopedic trauma intramedullary rod, antegrade tibia 10° bend, 12.5 mm diameter, 240 mm length

NUVASIVE SPECIALIZED ORTHOPEDICS, INC.

Tibia nail, sterile

• Primary Device ID: 00812258027520
• NIH Device Record Key: 015b5cb6-0479-458f-ba62-dbdd1499b74a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PRECICE® Trauma Nail System
• Version Model Number: CDT12.5-30T240
• Catalog Number: CDT12.5-30T240
• Company DUNS: 837845234
• Company Name: NUVASIVE SPECIALIZED ORTHOPEDICS, INC.
• 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: 855-435-5477
• Email: csdepartment@nuvasive.com
• Phone: 855-435-5477
• Email: csdepartment@nuvasive.com
• Phone: 855-435-5477
• Email: csdepartment@nuvasive.com
• Phone: 855-435-5477
• Email: csdepartment@nuvasive.com
• Phone: 855-435-5477
• Email: csdepartment@nuvasive.com
• Phone: 855-435-5477
• Email: csdepartment@nuvasive.com
• Phone: 855-435-5477
• Email: csdepartment@nuvasive.com
• Phone: 855-435-5477
• Email: csdepartment@nuvasive.com
• Phone: 855-435-5477
• Email: csdepartment@nuvasive.com
• Phone: 855-435-5477
• Email: csdepartment@nuvasive.com

Device Dimensions

• Outer Diameter: 12.5 Millimeter
• Outer Diameter: 12.5 Millimeter
• Outer Diameter: 12.5 Millimeter
• Outer Diameter: 12.5 Millimeter
• Outer Diameter: 12.5 Millimeter
• Outer Diameter: 12.5 Millimeter
• Outer Diameter: 12.5 Millimeter
• Outer Diameter: 12.5 Millimeter
• Outer Diameter: 12.5 Millimeter
• Outer Diameter: 12.5 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00812258027520 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162927

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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-09-20

On-Brand Devices [PRECICE® Trauma Nail System]

• 00812258028770: Orthopedic surgical instrument (fracture reducer-humerus) - for use with the trauma intramedulla
• 00812258028404: 5 mm Hex Locking Bolt Driver
• 00812258028329: Locking Key, Long
• 00812258028312: 3.9mm Drill Bit, Short
• 00812258028305: 3.4mm Drill Bit, Short
• 00812258028299: 4.3mm Drill Bit, Long
• 00812258028077: End Cap for PRECICE Trauma Intramedullary Nail System Implant
• 00812258028060: End Cap for PRECICE Trauma Intramedullary Nail System Implant
• 00812258028053: End Cap for PRECICE Trauma Intramedullary Nail System Implant
• 00812258028046: End Cap for PRECICE Trauma Intramedullary Nail System Implant
• 00812258028039: End Cap for PRECICE Trauma Intramedullary Nail System Implant
• 00812258028022: PACKAGED 2MM X 175MM DRILL TIP K-WIRE
• 00812258028015: 5.0 mm Threaded Locking Screw 110 mm Length
• 00812258028008: 5.0 mm Threaded Locking Screw 105 mm Length
• 00812258027995: 5.0 mm Threaded Locking Screw 100 mm Length
• 00812258027988: 5.0 mm Threaded Locking Screw 95 mm Length
• 00812258027971: 5.0 mm Threaded Locking Screw 90 mm Length
• 00812258027964: 5.0 mm Threaded Locking Screw 85 mm Length
• 00812258027957: 5.0 mm Threaded Locking Screw 80 mm Length
• 00812258027940: 5.0 mm Threaded Locking Screw 75 mm Length
• 00812258027933: 5.0 mm Threaded Locking Screw 72.5 mm Length
• 00812258027926: 5.0 mm Threaded Locking Screw 70 mm Length
• 00812258027919: 5.0 mm Threaded Locking Screw 67.5 mm Length
• 00812258027902: 5.0 mm Threaded Locking Screw 65 mm Length
• 00812258027896: 5.0 mm Threaded Locking Screw 62.5 mm Length
• 00812258027889: 5.0 mm Threaded Locking Screw 60 mm Length
• 00812258027872: 5.0 mm Threaded Locking Screw 57.5 mm Length
• 00812258027865: 5.0 mm Threaded Locking Screw 55 mm Length
• 00812258027858: 5.0 mm Threaded Locking Screw 52.5 mm Length
• 00812258027841: 5.0 mm Threaded Locking Screw 50 mm Length
• 00812258027834: 5.0 mm Threaded Locking Screw 47.5 mm Length
• 00812258027827: 5.0 mm Threaded Locking Screw 45 mm Length
• 00812258027810: 5.0 mm Threaded Locking Screw 42.5 mm Length
• 00812258027803: 5.0 mm Threaded Locking Screw 40 mm Length
• 00812258027797: 5.0 mm Threaded Locking Screw 37.5 mm Length
• 00812258027780: 5.0 mm Threaded Locking Screw 35 mm Length
• 00812258027773: 5.0 mm Threaded Locking Screw 32.5 mm Length
• 00812258027766: 5.0 mm Threaded Locking Screw 30 mm Length
• 00812258027759: 5.0 mm Threaded Locking Screw 27.5 mm Length
• 00812258027742: 5.0 mm Threaded Locking Screw 25 mm Length
• 00812258027735: 5.0 mm Threaded Locking Screw 22.5 mm Length
• 00812258027728: 5.0 mm Threaded Locking Screw 20 mm Length
• 00812258027711: Orthopedic trauma intramedullary rod, antegrade tibia 10° bend, 12.5 mm diameter, 375 mm length
• 00812258027704: Orthopedic trauma intramedullary rod, antegrade tibia 10° bend, 12.5 mm diameter, 360 mm length
• 00812258027698: Orthopedic trauma intramedullary rod, antegrade tibia 10° bend, 12.5 mm diameter, 345 mm length
• 00812258027681: Orthopedic trauma intramedullary rod, antegrade tibia 10° bend, 12.5 mm diameter, 330 mm length
• 00812258027674: Orthopedic trauma intramedullary rod, antegrade tibia 10° bend, 12.5 mm diameter, 315 mm length
• 00812258027667: Orthopedic trauma intramedullary rod, antegrade tibia 10° bend, 12.5 mm diameter, 300 mm length
• 00812258027650: Orthopedic trauma intramedullary rod, antegrade tibia 10° bend, 12.5 mm diameter, 285 mm length
• 00812258027643: Orthopedic trauma intramedullary rod, antegrade tibia 10° bend, 12.5 mm diameter, 270 mm length