Lotus Posterior Cervical/Thoracic Spinal System— 510(k) K151705

Substantially Equivalent

Spinal Elements, Inc.

FDA 510(k) clearance K151705 for Lotus Posterior Cervical/Thoracic Spinal System, Substantially Equivalent on 2015-09-03. Applicant: Spinal Elements, Inc..

Clearance details

Applicant: Spinal Elements, Inc.
Product code: Code NKG
Advisory panel: Orthopedic
Date received: 2015-06-24
Decision date: 2015-09-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carlsbad, CA, US

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Adverse events under product code NKG

product code NKG

Death: 15
Injury: 1,090
Malfunction: 529
Total: 1,634

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.