CyclaPlex Correction System— 510(k) K183094

Name: FDA 510(k) clearance K183094
Creator: U.S. Food and Drug Administration
Published: 2019-04-26

Substantially Equivalent

Cycla Orthopedics, Ltd.

FDA 510(k) clearance K183094 for CyclaPlex Correction System, Substantially Equivalent on 2019-04-26. Applicant: Cycla Orthopedics, Ltd.. Device class: 2.

Clearance details

Applicant: Cycla Orthopedics, Ltd.
Product code: Code HTN
Device class: Class 2
Regulation: 21 CFR 888.3030
Advisory panel: Orthopedic
Date received: 2018-11-07
Decision date: 2019-04-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bat Shlomo, IL

Download summary PDF View on FDA.gov ↗

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Adverse events under product code HTN

product code HTN

Injury: 310
Malfunction: 639
Total: 949

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.