Intra medullary endo-transilluminating device (iMET device)— 510(k) K163037

Substantially Equivalent

WeMED Bio-Tech, Inc.

FDA 510(k) clearance K163037 for Intra medullary endo-transilluminating device (iMET device), Substantially Equivalent on 2017-02-17. Applicant: WeMED Bio-Tech, Inc..

Clearance details

Applicant: WeMED Bio-Tech, Inc.
Product code: Code HRX
Advisory panel: Orthopedic
Date received: 2016-10-31
Decision date: 2017-02-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Taipei City, TW

Download summary PDF View on FDA.gov ↗

Adverse events under product code HRX

product code HRX

Injury: 623
Malfunction: 11,257
Total: 11,880

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.