Mitchell Ponseti® Bracing System

GUDID 00810060888438

MD ORTHOPAEDICS, INC.

Ankle/foot orthosis

• Primary Device ID: 00810060888438
• NIH Device Record Key: 90e6a4c2-4448-491c-ae0c-d20bd3ca75a0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Mitchell Ponseti® Bracing System
• Version Model Number: HDWEKIT
• Company DUNS: 146220269
• Company Name: MD ORTHOPAEDICS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810060888438 [Primary]

FDA Product Code

• ITN: Splint, Denis Brown

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-03-20
• Device Publish Date: 2026-03-12

On-Brand Devices [Mitchell Ponseti® Bracing System]

• 00810060888605: Large Pressure Saddle
• 00810060888599: Small Pressure Saddle
• 00810060888582: UNIVERSAL MOUNT KIT
• 00810060888438: HDWEKIT