MedCAD® AccuStride System— 510(k) K252064
Substantially EquivalentMedcad
FDA 510(k) clearance K252064 for MedCAD® AccuStride System, Substantially Equivalent on 2026-03-27. Applicant: Medcad. Device class: 2.
Summary
Medcad's MedCAD® AccuStride System is filed under PBF, orthopaedic surgical planning and instrument guides. The record doesn't describe the system beyond its name and that code name.
Class II, 21 CFR 888.3030. It was a Traditional 510(k), and Orthopedic is both the classification panel and the review panel.
Medcad filed from Dallas, Texas. The decision came 269 calendar days after FDA received it (July 1, 2025 to March 27, 2026).
Clearance details
- Applicant
- Medcad
- Product code
- Product code PBF
- Device class
- Class 2
- Regulation
- 21 CFR 888.3030
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Dallas, TX, US
Recent devices under product code PBF
view allMore clearances from Medcad
view allAdverse events under product code PBF
product code PBF- Injury
- 180
- Total
- 180
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.