T-Button® A Adjustable Loop UHMWPE Suture PEEK Button, Close Button, T-Button® S Adjustable Loop UHMWPE Suture PEEK Button, Open Button— 510(k) K231404

Substantially Equivalent

Healthium Medtech Limited

FDA 510(k) clearance K231404 for T-Button® A Adjustable Loop UHMWPE Suture PEEK Button, Close Button, T-Button® S Adjustable Loop UHMWPE Suture PEEK Button, Open Button, Substantially Equivalent on 2023-08-04. Applicant: Healthium Medtech Limited.

Clearance details

Applicant: Healthium Medtech Limited
Product code: Code MBI
Advisory panel: Orthopedic
Date received: 2023-05-15
Decision date: 2023-08-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bangalore, IN

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.