FRAMEWALKER— 510(k) K111993

Name: FDA 510(k) clearance K111993
Creator: U.S. Food and Drug Administration
Published: 2011-10-24

Substantially Equivalent

Quantum Medical Concepts, LLC

FDA 510(k) clearance K111993 for FRAMEWALKER, Substantially Equivalent on 2011-10-24. Applicant: Quantum Medical Concepts, LLC. Device class: 2.

Clearance details

Applicant: Quantum Medical Concepts, LLC
Product code: Code KTT
Device class: Class 2
Regulation: 21 CFR 888.3030
Advisory panel: Orthopedic
Date received: 2011-07-13
Decision date: 2011-10-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Portland, OR, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code KTT

product code KTT

Death: 11
Injury: 3,097
Malfunction: 1,261
Total: 4,369

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.