PRECICE® Plating System LP4.5-PLT4B

GUDID 00887517021441

PRECICE Plate 4.5mm Proximal Tibia Plate, Left, 45mm, Bump

NUVASIVE SPECIALIZED ORTHOPEDICS, INC.

Long bone distraction plate, magnetic

• Primary Device ID: 00887517021441
• NIH Device Record Key: 2b3dbe68-b501-4f18-bea7-cae7a68f5c09
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PRECICE® Plating System
• Version Model Number: LP4.5-PLT4B
• Catalog Number: LP4.5-PLT4B
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00887517021441 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192181

FDA Product Code

• HRS: Plate, Fixation, Bone

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: 2020-03-12
• Device Publish Date: 2020-01-06

On-Brand Devices [PRECICE® Plating System]

• 00887517021915: PRECICE Plate 4.5mm Distal Femur Plate, Left, 35mm, 0-Hole
• 00887517021908: PRECICE Plate 4.5mm Distal Femur Plate, Left, 35mm, 1-Hole
• 00887517021892: PRECICE Plate 4.5mm Distal Femur Plate, Left, 35mm, 2-Hole
• 00887517021885: PRECICE Plate 4.5mm Distal Femur Plate, Left, 35mm, Bump
• 00887517021878: PRECICE Plate 4.5mm Distal Femur Plate, Left, 45mm, 0-Hole
• 00887517021861: PRECICE Plate 4.5mm Distal Femur Plate, Left, 45mm, 1-Hole
• 00887517021854: PRECICE Plate 4.5mm Distal Femur Plate, Left, 45mm, 2-Hole
• 00887517021847: PRECICE Plate 4.5mm Distal Femur Plate, Left, 45mm, Bump
• 00887517021830: PRECICE Plate 4.5mm Distal Femur Plate, Right, 35mm, 0-Hole
• 00887517021823: PRECICE Plate 4.5mm Distal Femur Plate, Right, 35mm, 1-Hole
• 00887517021816: PRECICE Plate 4.5mm Distal Femur Plate, Right, 35mm, 2-Hole
• 00887517021809: PRECICE Plate 4.5mm Distal Femur Plate, Right, 35mm, Bump
• 00887517021793: PRECICE Plate 4.5mm Distal Femur Plate, Right, 45mm, 0-Hole
• 00887517021786: PRECICE Plate 4.5mm Distal Femur Plate, Right, 45mm, 1-Hole
• 00887517021779: PRECICE Plate 4.5mm Distal Femur Plate, Right, 45mm, 2-Hole
• 00887517021762: PRECICE Plate 4.5mm Distal Femur Plate, Right, 45mm, Bump
• 00887517021755: PRECICE Plate 4.5mm Posteromedial Proximal Tibia Plate, Left, 35mm, 0-Hole
• 00887517021748: PRECICE Plate 4.5mm Posteromedial Proximal Tibia Plate, Left, 35mm, 1-Hole
• 00887517021731: PRECICE Plate 4.5mm Posteromedial Proximal Tibia Plate, Left, 35mm, 2-Hole
• 00887517021724: PRECICE Plate 4.5mm Posteromedial Proximal Tibia Plate, Left, 35mm, Bump
• 00887517021717: PRECICE Plate 4.5mm Posteromedial Proximal Tibia Plate, Left, 45mm, 0-Hole
• 00887517021700: PRECICE Plate 4.5mm Posteromedial Proximal Tibia Plate, Left, 45mm, 0-Hole
• 00887517021694: PRECICE Plate 4.5mm Posteromedial Proximal Tibia Plate, Left, 45mm, 2-Hole
• 00887517021687: PRECICE Plate 4.5mm Posteromedial Proximal Tibia Plate, Left, 45mm, Bump
• 00887517021670: PRECICE Plate 4.5mm Posteromedial Proximal Tibia Plate, Right, 35mm, 0-Hole
• 00887517021663: PRECICE Plate 4.5mm Posteromedial Proximal Tibia Plate, Right, 35mm, 1-Hole
• 00887517021656: PRECICE Plate 4.5mm Posteromedial Proximal Tibia Plate, Right, 35mm, 2-Hole
• 00887517021649: PRECICE Plate 4.5mm Posteromedial Proximal Tibia Plate, Right, 35mm, Bump
• 00887517021632: PRECICE Plate 4.5mm Posteromedial Proximal Tibia Plate, Right, 45mm, 0-Hole
• 00887517021625: PRECICE Plate 4.5mm Posteromedial Proximal Tibia Plate, Right, 45mm, 1-Hole
• 00887517021618: PRECICE Plate 4.5mm Posteromedial Proximal Tibia Plate, Right, 45mm, 2-Hole
• 00887517021601: PRECICE Plate 4.5mm Posteromedial Proximal Tibia Plate, Right, 45mm, Bump
• 00887517021595: PRECICE Plate 4.5mm Proximal Femur Plate, Left, 35mm, 0-Hole
• 00887517021588: PRECICE Plate 4.5mm Proximal Femur Plate, Left, 35mm, 1-Hole
• 00887517021571: PRECICE Plate 4.5mm Proximal Femur Plate, Left, 35mm, 2-Hole
• 00887517021564: PRECICE Plate 4.5mm Proximal Femur Plate, Left, 35mm, Bump
• 00887517021557: PRECICE Plate 4.5mm Proximal Femur Plate, Left, 45mm, 0-Hole
• 00887517021540: PRECICE Plate 4.5mm Proximal Femur Plate, Left, 45mm, 1-Hole
• 00887517021533: PRECICE Plate 4.5mm Proximal Femur Plate, Left, 45mm, 2-Hole
• 00887517021526: PRECICE Plate 4.5mm Proximal Femur Plate, Left, 45mm, Bump
• 00887517021519: PRECICE Plate 4.5mm Proximal Tibia Plate, Left, 35mm, 0-Hole
• 00887517021502: PRECICE Plate 4.5mm Proximal Tibia Plate, Left, 35mm, 1-Hole
• 00887517021496: PRECICE Plate 4.5mm Proximal Tibia Plate, Left, 35mm, 2-Hole
• 00887517021489: PRECICE Plate 4.5mm Proximal Tibia Plate, Left, 35mm, Bump
• 00887517021472: PRECICE Plate 4.5mm Proximal Tibia Plate, Left, 45mm, 0-Hole
• 00887517021465: PRECICE Plate 4.5mm Proximal Tibia Plate, Left, 45mm, 1-Hole
• 00887517021458: PRECICE Plate 4.5mm Proximal Tibia Plate, Left, 45mm, 2-Hole
• 00887517021441: PRECICE Plate 4.5mm Proximal Tibia Plate, Left, 45mm, Bump
• 00887517021434: PRECICE Plate 4.5mm Proximal Femur Plate, Right, 35mm, 0-Hole
• 00887517021427: PRECICE Plate 4.5mm Proximal Femur Plate, Right, 35mm, 1-Hole