CyclaPlex Correction System— 510(k) K183094

Substantially Equivalent

Cycla Orthopedics, Ltd.

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

Clearance details

Applicant: Cycla Orthopedics, Ltd.
Product code: Code HTN
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 ↗

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.