AccuStride System

Basic Information

• Brand Name: AccuStride System
• Primary DI: 00081000763324
• Version / Model: MC-KST000
• Catalog Number: MC-KST000
• Company Name: Medcad
• Labeler DUNS: 144723868
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-05-05
• Public Version: 2
• Public Version Date: 2025-06-11
• Public Version Status: Update
• Public Device Record Key: 405aae84-da62-4573-96b3-d3a4215ac331
• Distribution End Date: 2025-06-09

Device Description

Surgical Planning Kit

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
PBF	Orthopaedic Surgical Planning And Instrument Guides	Orthopedic	888.3030	2

GMDN Terms

Code	Name	Definition	Implantable	Status
60826	Custom-made orthopaedic/craniofacial surgical guide	A custom-made surgical instrument intended to be used in an orthopaedic and/or craniomaxillofacial procedure (e.g., osteotomy, arthroplasty, tumour resection, distraction osteogenesis, cranial vault reconstruction) to assist in the intraoperative orientation of implant components, outlining the desired cut-line, and/or guiding of surgical instruments (e.g., surgical drill, oscillating cutting saw). It is made of synthetic polymer materials and is typically manufactured by 3-D printing and CAD/CAM techniques to match the patient-specific contours of the target anatomical site. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00081000763324	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K241811	000