AccuStride System MC-3D134

GUDID 00810007633305

ANATOMICAL MODEL, INTRAOPERATIVE, TIBIA, FIBULA

Medcad

Custom-made orthopaedic/craniofacial surgical guide

• Primary Device ID: 00810007633305
• NIH Device Record Key: 63eea79a-d543-43bc-8bd2-9dd1e4efb086
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AccuStride System
• Version Model Number: MC-3D134
• Catalog Number: MC-3D134
• Company DUNS: 144723868
• Company Name: Medcad
• Device Count: 1
• DM Exempt: false
• 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: true
• Manufacturing Date: false
• 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: (214) 453-8864
• Email: support@medcad.net
• Phone: (214) 453-8864
• Email: support@medcad.net
• Phone: (214) 453-8864
• Email: support@medcad.net
• Phone: (214) 453-8864
• Email: support@medcad.net
• Phone: (214) 453-8864
• Email: support@medcad.net
• Phone: (214) 453-8864
• Email: support@medcad.net
• Phone: (214) 453-8864
• Email: support@medcad.net
• Phone: (214) 453-8864
• Email: support@medcad.net
• Phone: (214) 453-8864
• Email: support@medcad.net
• Phone: (214) 453-8864
• Email: support@medcad.net
• Phone: (214) 453-8864
• Email: support@medcad.net
• Phone: (214) 453-8864
• Email: support@medcad.net
• Phone: (214) 453-8864
• Email: support@medcad.net

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810007633305 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K241811

FDA Product Code

• PBF: Orthopaedic Surgical Planning And Instrument Guides

Sterilization

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

[00810007633305]

Moist Heat or Steam Sterilization

[00810007633305]

Moist Heat or Steam Sterilization

[00810007633305]

Moist Heat or Steam Sterilization

[00810007633305]

Moist Heat or Steam Sterilization

[00810007633305]

Moist Heat or Steam Sterilization

[00810007633305]

Moist Heat or Steam Sterilization

[00810007633305]

Moist Heat or Steam Sterilization

[00810007633305]

Moist Heat or Steam Sterilization

[00810007633305]

Moist Heat or Steam Sterilization

[00810007633305]

Moist Heat or Steam Sterilization

[00810007633305]

Moist Heat or Steam Sterilization

[00810007633305]

Moist Heat or Steam Sterilization

[00810007633305]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-07-08
• Device Publish Date: 2025-06-30

On-Brand Devices [AccuStride System ]

• 00810007633268: Titanium Surgical Guide
• 00810007633251: Surgical Plan - Report
• 00081000763324: Surgical Planning Kit
• 00810007633244: Surgical Planning Kit
• 00810007633312: ANATOMICAL MODEL, INTRAOPERATIVE, FOOT & ANKLE
• 00810007633305: ANATOMICAL MODEL, INTRAOPERATIVE, TIBIA, FIBULA
• 00810007633299: ANATOMICAL MODEL, INTRAOPERATIVE, FOOT, TIBIA, FIBULA
• 00810007633282: ANATOMICAL MODEL, INTRAOPERATIVE, FOOT