Mega Plus MIS Spine System— 510(k) K200981

Substantially Equivalent

Bk Meditech, Co., Ltd.

FDA 510(k) clearance K200981 for Mega Plus MIS Spine System, Substantially Equivalent on 2020-08-11. Applicant: Bk Meditech, Co., Ltd..

Clearance details

Applicant: Bk Meditech, Co., Ltd.
Product code: Code NKB
Advisory panel: Orthopedic
Date received: 2020-04-14
Decision date: 2020-08-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hwaseong-Si, KR

Download summary PDF View on FDA.gov ↗

Adverse events under product code NKB

product code NKB

Death: 27
Injury: 5,033
Malfunction: 4,140
Total: 9,200

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.