VersaTap, VersaLat, DueLock, VersaTi, MiniTi— 510(k) K212381

Substantially Equivalent

Ortho-Design (Pty), Ltd.

FDA 510(k) clearance K212381 for VersaTap, VersaLat, DueLock, VersaTi, MiniTi, Substantially Equivalent on 2021-12-06. Applicant: Ortho-Design (Pty), Ltd..

Clearance details

Applicant: Ortho-Design (Pty), Ltd.
Product code: Code MBI
Advisory panel: Orthopedic
Date received: 2021-08-02
Decision date: 2021-12-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pretoria, ZA

Download summary PDF View on FDA.gov ↗

Adverse events under product code MBI

product code MBI

Injury: 3,163
Malfunction: 13,006
Other: 2
Total: 16,171

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.