PRECICE STRYDE System PS10.0-50B235

GUDID 00887517950741

Antegrade Femur Piriformis Straight Nail

NUVASIVE SPECIALIZED ORTHOPEDICS, INC.

Femur nail, sterile Femur nail Femur nail Femur nail Femur nail Femur nail Femur nail Femur nail Femur nail

• Primary Device ID: 00887517950741
• NIH Device Record Key: ac2ee1ec-124f-403b-9113-fbd489cd8feb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PRECICE STRYDE System
• Version Model Number: PS10.0-50B235
• Catalog Number: PS10.0-50B235
• 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: 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	00887517950741 [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: 2018-09-17
• Device Publish Date: 2018-08-17

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