PRECICE® STRYDE System PS13.0-65C250

GUDID 00887517951106

Antegrade Tibia 10° Bend

NUVASIVE SPECIALIZED ORTHOPEDICS, INC.

Tibia nail, sterile

• Primary Device ID: 00887517951106
• NIH Device Record Key: 47bdf680-7923-4dcf-af3f-f4f93ad895ab
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PRECICE® STRYDE System
• Version Model Number: PS13.0-65C250
• Catalog Number: PS13.0-65C250
• 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: 855-435-5478
• Email: csdepartment@nuvasive.com
• Phone: 855-435-5478
• Email: csdepartment@nuvasive.com
• Phone: 855-435-5478
• Email: csdepartment@nuvasive.com
• Phone: 855-435-5478
• Email: csdepartment@nuvasive.com
• Phone: 855-435-5478
• Email: csdepartment@nuvasive.com
• Phone: 855-435-5478
• Email: csdepartment@nuvasive.com
• Phone: 855-435-5478
• Email: csdepartment@nuvasive.com
• Phone: 855-435-5478
• Email: csdepartment@nuvasive.com
• Phone: 855-435-5478
• Email: csdepartment@nuvasive.com

Device Dimensions

• Outer Diameter: 13 Millimeter
• Outer Diameter: 13 Millimeter
• Outer Diameter: 13 Millimeter
• Outer Diameter: 13 Millimeter
• Outer Diameter: 13 Millimeter
• Outer Diameter: 13 Millimeter
• Outer Diameter: 13 Millimeter
• Outer Diameter: 13 Millimeter
• Outer Diameter: 13 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00887517951106 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180503

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: 2018-11-19
• Device Publish Date: 2018-10-19

On-Brand Devices [PRECICE® STRYDE System]

• 00887517951366: Antegrade Femur Trochanter 10° Bend
• 00887517951359: Antegrade Femur Trochanter 10° Bend
• 00887517951342: Antegrade Femur Trochanter 10° Bend
• 00887517951335: Antegrade Femur Trochanter 10° Bend
• 00887517951328: Antegrade Femur Trochanter 10° Bend
• 00887517951311: Antegrade Femur Trochanter 10° Bend
• 00887517951304: Antegrade Femur Trochanter 10° Bend
• 00887517951298: Antegrade Femur Trochanter 10° Bend
• 00887517951281: Antegrade Femur Trochanter 10° Bend
• 00887517951274: Antegrade Femur Trochanter 10° Bend
• 00887517951267: Antegrade Femur Trochanter 10° Bend
• 00887517951250: Antegrade Femur Trochanter 10° Bend
• 00887517951243: Antegrade Femur Trochanter 10° Bend
• 00887517951229: Antegrade Femur Trochanter 10° Bend
• 00887517951212: Antegrade Femur Trochanter 10° Bend
• 00887517951205: Antegrade Femur Trochanter 10° Bend
• 00887517951199: Antegrade Femur Trochanter 10° Bend
• 00887517951182: Antegrade Femur Trochanter 10° Bend
• 00887517951175: Antegrade Femur Trochanter 10° Bend
• 00887517950604: Retrograde Femur 10° Bend
• 00887517972033: PRECICE Drill Bit, 340mm 5.0 Step
• 00887517972026: PRECICE Drill Bit, 155mm 5.0 Step
• 00887517972019: PRECICE Drill Bit, 155mm 4.5 Step
• 00887517972002: PRECICE Drill Bit, 155mm 4.0 Step
• 00887517952868: 5.0mm x 80mm Locking Screws, Partially T
• 00887517952851: 5.0mm x 75mm Locking Screws, Partially T
• 00887517952844: 5.0mm x 70mm Locking Screws, Partially T
• 00887517952837: 5.0mm x 65mm Locking Screws, Partially T
• 00887517952820: 5.0mm x 60mm Locking Screws, Partially T
• 00887517952813: 5.0mm x 55mm Locking Screws, Partially T
• 00887517952806: 5.0mm x 50mm Locking Screws, Partially T
• 00887517952790: 5.0mm x 47.5mm Locking Screws, Partially
• 00887517952783: 5.0mm x 45mm Locking Screws, Partially T
• 00887517952776: 5.0mm x 42.5mm Locking Screws, Partially
• 00887517952769: 5.0mm x 40mm Locking Screws, Partially T
• 00887517952752: 5.0mm x 37.5mm Locking Screws, Partially
• 00887517952745: 5.0mm x 35mm Locking Screws, Partially T
• 00887517952738: 5.0mm x 32.5mm Locking Screws, Partially
• 00887517952721: 5.0mm x 30mm Locking Screws, Partially T
• 00887517952714: 5.0mm x 27.5mm Locking Screws, Partially
• 00887517952707: 5.0mm x 25mm Locking Screws, Partially T
• 00887517952691: 5.0mm x 22.5mm Locking Screws, Partially
• 00887517952684: 5.0mm x 20mm Locking Screws, Partially T
• 00887517952677: 4.5mm x 80mm Locking Screws, Partially T
• 00887517952660: 4.5mm x 75mm Locking Screws, Partially T
• 00887517952653: 4.5mm x 70mm Locking Screws, Partially T
• 00887517952646: 4.5mm x 65mm Locking Screws, Partially T
• 00887517952639: 4.5mm x 60mm Locking Screws, Partially T
• 00887517952622: 4.5mm x 55mm Locking Screws, Partially T
• 00887517952615: 4.5mm x 50mm Locking Screws, Partially T