AccelFix Lumbar Plate System— 510(k) K192481

Substantially Equivalent

L&K BIOMED Co., Ltd.

FDA 510(k) clearance K192481 for AccelFix Lumbar Plate System, Substantially Equivalent on 2020-07-28. Applicant: L&K BIOMED Co., Ltd..

Clearance details

Applicant: L&K BIOMED Co., Ltd.
Product code: Code KWQ
Advisory panel: Orthopedic
Date received: 2019-09-10
Decision date: 2020-07-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Yongin-Si, KR

Download summary PDF View on FDA.gov ↗

Adverse events under product code KWQ

product code KWQ

Death: 8
Injury: 1,212
Malfunction: 1,233
Total: 2,453

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.