AccelFix Lumbar Expandable Cage System— 510(k) K231680

Substantially Equivalent

L&K BIOMED Co., Ltd.

FDA 510(k) clearance K231680 for AccelFix Lumbar Expandable Cage System, Substantially Equivalent on 2023-08-24. Applicant: L&K BIOMED Co., Ltd..

Clearance details

Applicant: L&K BIOMED Co., Ltd.
Product code: Code MAX
Advisory panel: Orthopedic
Date received: 2023-06-09
Decision date: 2023-08-24
Decision: Substantially Equivalent
Clearance type: Special
Location: Yongin-Si, KR

Download summary PDF View on FDA.gov ↗

Adverse events under product code MAX

product code MAX

Death: 13
Injury: 1,305
Malfunction: 2,885
Total: 4,203

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.