LOTUS— 510(k) K131427

Substantially Equivalent

Spinal Elements, Inc.

FDA 510(k) clearance K131427 for LOTUS, Substantially Equivalent on 2013-10-24. Applicant: Spinal Elements, Inc..

Clearance details

Applicant: Spinal Elements, Inc.
Product code: Code KWP
Advisory panel: Orthopedic
Date received: 2013-05-17
Decision date: 2013-10-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carlsbad, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code KWP

product code KWP

Death: 7
Injury: 1,539
Malfunction: 1,519
Total: 3,065

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.