PRECICE® Bone Transport System BT10-80C320-7

GUDID 00887517980229

Antegrade Tibia 10° Bend, 10.0mm x 320mm, 7/8cm ST

NUVASIVE SPECIALIZED ORTHOPEDICS, INC.

Tibia nail, sterile

• Primary Device ID: 00887517980229
• NIH Device Record Key: 919dbb35-3f91-480c-a224-1b244400e940
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PRECICE® Bone Transport System
• Version Model Number: BT10-80C320-7
• Catalog Number: BT10-80C320-7
• 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

Device Dimensions

• Outer Diameter: 10 Millimeter
• Outer Diameter: 10 Millimeter
• Outer Diameter: 10 Millimeter
• Outer Diameter: 10 Millimeter
• Outer Diameter: 10 Millimeter
• Outer Diameter: 10 Millimeter
• Outer Diameter: 10 Millimeter
• Outer Diameter: 10 Millimeter
• Outer Diameter: 10 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00887517980229 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182170

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: 2
• Public Version Date: 2019-04-15
• Device Publish Date: 2019-02-21

On-Brand Devices [PRECICE® Bone Transport System]

• 00887517981028: Recon Antegrade Femur Piriformis Straight, 10.0mm x 400mm, 7/10cm ST
• 00887517980960: Recon Antegrade Femur Trochanter 10° Bend, 10.0mm x 400mm, 7/10cm ST
• 00887517980908: Retrograde Femur Straight – Three Holes, 10.0mm x 400mm, 7/10cm ST
• 00887517980847: Antegrade Tibia 10° Bend – Three Holes, 10.0mm x 400mm, 7/10cm ST
• 00887517980717: Retrograde Femur 10° Bend, 10.0mm x 280mm, 6/6cm ST
• 00887517980700: Antegrade Femur Piriformis Straight, 10.0mm x 280mm, 6/6cm ST
• 00887517980694: Antegrade Femur Piriformis Straight, 10.0mm x 280mm, 6/6cm ST
• 00887517980687: Antegrade Tibia 10° Bend, 10.0mm x 280mm, 6/6cm ST
• 00887517980670: Antegrade Femur Trochanter 10° Bend, 10.0mm x 280mm, 6/6cm ST
• 00887517980663: Antegrade Femur Trochanter 10° Bend, 10.0mm x 280mm, 6/6cm ST
• 00887517980656: Retrograde Femur Straight, 10.0mm x 280mm, 6/6cm ST
• 00887517980649: Retrograde Femur 5° Bend – Three Holes, 10.0mm x 280mm, 6/6cm ST
• 00887517980632: Recon Antegrade Femur Piriformis Straight, 10.0mm x 280mm, 6/6cm ST
• 00887517980625: Recon Antegrade Femur Trochanter 10° Bend, 10.0mm x 280mm, 6/6cm ST
• 00887517980618: Retrograde Femur Straight – Three Holes, 10.0mm x 280mm, 6/6cm ST
• 00887517980601: Antegrade Tibia 10° Bend – Three Holes, 10.0mm x 280mm, 6/6cm ST
• 00887517980595: Retrograde Femur 10° Bend, 10.0mm x 280mm, 6/6cm ST
• 00887517980588: Retrograde Femur Straight, 10.0mm x 280mm, 6/6cm ST
• 00887517980571: Retrograde Femur 10° Bend, 10.0mm x 300mm, 5/7cm ST
• 00887517980564: Retrograde Femur 10° Bend, 10.0mm x 300mm, 7/7cm ST
• 00887517980557: Antegrade Femur Piriformis Straight, 10.0mm x 300mm, 5/7cm ST
• 00887517980540: Antegrade Femur Piriformis Straight, 10.0mm x 300mm, 7/7cm ST
• 00887517980533: Antegrade Femur Piriformis Straight, 10.0mm x 300mm, 5/7cm ST
• 00887517980526: Antegrade Femur Piriformis Straight, 10.0mm x 300mm, 7/7cm ST
• 00887517980519: Antegrade Tibia 10° Bend, 10.0mm x 300mm, 5/7cm ST
• 00887517980502: Antegrade Tibia 10° Bend, 10.0mm x 300mm, 7/7cm ST
• 00887517980496: Antegrade Femur Trochanter 10° Bend, 10.0mm x 300mm, 5/7cm ST
• 00887517980489: Antegrade Femur Trochanter 10° Bend, 10.0mm x 300mm, 7/7cm ST
• 00887517980472: Antegrade Femur Trochanter 10° Bend, 10.0mm x 300mm, 5/7cm ST
• 00887517980465: Antegrade Femur Trochanter 10° Bend, 10.0mm x 300mm, 7/7cm ST
• 00887517980458: Retrograde Femur Straight, 10.0mm x 300mm, 5/7cm ST
• 00887517980441: Retrograde Femur Straight, 10.0mm x 300mm, 7/7cm ST
• 00887517980434: Retrograde Femur 5° Bend – Three Holes, 10.0mm x 300mm, 5/7cm ST
• 00887517980427: Retrograde Femur 5° Bend – Three Holes, 10.0mm x 300mm, 7/7cm ST
• 00887517980410: Recon Antegrade Femur Piriformis Straight, 10.0mm x 300mm, 5/7cm ST
• 00887517980403: Recon Antegrade Femur Piriformis Straight, 10.0mm x 300mm, 7/7cm ST
• 00887517980397: Recon Antegrade Femur Trochanter 10° Bend, 10.0mm x 300mm, 5/7cm ST
• 00887517980380: Recon Antegrade Femur Trochanter 10° Bend, 10.0mm x 300mm, 7/7cm ST
• 00887517980373: Retrograde Femur Straight – Three Holes, 10.0mm x 300mm, 5/7cm ST
• 00887517980366: Retrograde Femur Straight – Three Holes, 10.0mm x 300mm, 7/7cm ST
• 00887517980359: Antegrade Tibia 10° Bend – Three Holes, 10.0mm x 300mm, 5/7cm ST
• 00887517980342: Antegrade Tibia 10° Bend – Three Holes, 10.0mm x 300mm, 7/7cm ST
• 00887517980335: Retrograde Femur 10° Bend, 10.0mm x 300mm, 5/7cm ST
• 00887517980328: Retrograde Femur 10° Bend, 10.0mm x 300mm, 7/7cm ST
• 00887517980311: Retrograde Femur Straight, 10.0mm x 300mm, 5/7cm ST
• 00887517980304: Retrograde Femur Straight, 10.0mm x 300mm, 7/7cm ST
• 00887517980298: Retrograde Femur 10° Bend, 10.0mm x 320mm, 5/8cm ST
• 00887517980281: Retrograde Femur 10° Bend, 10.0mm x 320mm, 7/8cm ST
• 00887517980274: Antegrade Femur Piriformis Straight, 10.0mm x 320mm, 5/8cm ST
• 00887517980267: Antegrade Femur Piriformis Straight, 10.0mm x 320mm, 7/8cm ST