PROW FUSION-L— 510(k) K153665

Substantially Equivalent

Nlt Spine, Ltd.

FDA 510(k) clearance K153665 for PROW FUSION-L, Substantially Equivalent on 2016-09-15. Applicant: Nlt Spine, Ltd..

Clearance details

Applicant: Nlt Spine, Ltd.
Product code: Code MAX
Advisory panel: Orthopedic
Date received: 2015-12-21
Decision date: 2016-09-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kfar-Saba, IL

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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.