Leva(TM) Spacer System— 510(k) K150285

Substantially Equivalent

Spine Wave, Inc.

FDA 510(k) clearance K150285 for Leva(TM) Spacer System, Substantially Equivalent on 2015-03-05. Applicant: Spine Wave, Inc..

Clearance details

Applicant: Spine Wave, Inc.
Product code: Code MAX
Advisory panel: Orthopedic
Date received: 2015-02-05
Decision date: 2015-03-05
Decision: Substantially Equivalent
Clearance type: Special
Location: Shelton, CT, US

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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.