PRECICE Trauma Nail System CDT11.5-30T240

GUDID 00812258027322

Orthopedic trauma intramedullary rod, antegrade tibia 10° bend, 11.5 mm diameter, 240 mm length

NUVASIVE SPECIALIZED ORTHOPEDICS, INC.

Tibia nail, sterile Tibia nail, sterile Tibia nail Tibia nail Tibia nail Tibia nail Tibia nail Tibia nail Tibia nail Tibia nail

• Primary Device ID: 00812258027322
• NIH Device Record Key: d0053ae6-d540-4ef7-8903-b3452552da2a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PRECICE Trauma Nail System
• Version Model Number: CDT11.5-30T240
• Catalog Number: CDT11.5-30T240
• 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: 11.5 Millimeter
• Outer Diameter: 11.5 Millimeter
• Outer Diameter: 11.5 Millimeter
• Outer Diameter: 11.5 Millimeter
• Outer Diameter: 11.5 Millimeter
• Outer Diameter: 11.5 Millimeter
• Outer Diameter: 11.5 Millimeter
• Outer Diameter: 11.5 Millimeter
• Outer Diameter: 11.5 Millimeter
• Outer Diameter: 11.5 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00812258027322 [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: 2017-09-19

Devices Manufactured by NUVASIVE SPECIALIZED ORTHOPEDICS, INC.

• 00195377168276 - PRECICE Screws: 2024-01-19 5.0 mm X 100 mm Locking Screw, Fully Threaded
• 00195377168283 - PRECICE Screws: 2024-01-19 5.0 mm X 95 mm Locking Screw, Fully Threaded
• 00195377168290 - PRECICE Screws: 2024-01-19 5.0 mm X 80 mm Locking Screw, Fully Threaded
• 00195377168603 - PRECICE Screws: 2024-01-19 5.0 mm X 70 mm Locking Screw, Fully Threaded
• 00195377168610 - PRECICE Screws: 2024-01-19 5.0 mm X 60 mm Locking Screw, Fully Threaded
• 00195377168627 - PRECICE Screws: 2024-01-19 5.0 mm X 50 mm Locking Screw, Fully Threaded
• 00195377168634 - PRECICE Screws: 2024-01-19 5.0 mm X 45 mm Locking Screw, Fully Threaded
• 00195377168641 - PRECICE Screws: 2024-01-19 5.0 mm X 32.5 mm Locking Screw, Fully Threaded