PK High Tibial Osteotomy Correction System— 510(k) K182285

Substantially Equivalent

Paonan Biotech Co., Ltd.

FDA 510(k) clearance K182285 for PK High Tibial Osteotomy Correction System, Substantially Equivalent on 2019-06-20. Applicant: Paonan Biotech Co., Ltd..

Clearance details

Applicant: Paonan Biotech Co., Ltd.
Product code: Code KTW
Advisory panel: Orthopedic
Date received: 2018-08-23
Decision date: 2019-06-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Taipei City, TW

Download summary PDF View on FDA.gov ↗

Adverse events under product code KTW

product code KTW

Injury: 220
Total: 220

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.