Ortho Solutions Plating System

GUDID 05055662971088

FIBULA PLATE, POSTERIOR, RIGHT

ORTHO SOLUTIONS HOLDINGS LIMITED

Orthopaedic fixation plate, non-bioabsorbable

• Primary Device ID: 05055662971088
• NIH Device Record Key: dce61b3a-b72f-4588-a310-540004f064c4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ortho Solutions Plating System
• Version Model Number: OS731018R-NS
• Company DUNS: 218648211
• Company Name: ORTHO SOLUTIONS HOLDINGS LIMITED
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	05055662971088 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202764

FDA Product Code

• HRS: Plate, Fixation, Bone

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[05055662971088]

Moist Heat or Steam Sterilization

[05055662971088]

Moist Heat or Steam Sterilization

[05055662971088]

Moist Heat or Steam Sterilization

[05055662971088]

Moist Heat or Steam Sterilization

[05055662971088]

Moist Heat or Steam Sterilization

[05055662971088]

Moist Heat or Steam Sterilization

[05055662971088]

Moist Heat or Steam Sterilization

[05055662971088]

Moist Heat or Steam Sterilization

[05055662971088]

Moist Heat or Steam Sterilization

[05055662971088]

Moist Heat or Steam Sterilization

[05055662971088]

Moist Heat or Steam Sterilization

[05055662971088]

Moist Heat or Steam Sterilization

[05055662971088]

Moist Heat or Steam Sterilization

[05055662971088]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-02-19
• Device Publish Date: 2025-02-11

On-Brand Devices [Ortho Solutions Plating System]

• 05055662971101: VOLITION ANKLE FRACTURE PLATE CADDY 3
• 05055662971095: VOLITION ANKLE FRACTURE PLATE CADDY 2
• 05055662971088: FIBULA PLATE, POSTERIOR, RIGHT
• 05055662971071: FIBULA PLATE, POSTERIOR, LEFT