Perla® Posterior Cervico-Thoracic Fixation System— 510(k) K190071

Substantially Equivalent

Spineart

FDA 510(k) clearance K190071 for Perla® Posterior Cervico-Thoracic Fixation System, Substantially Equivalent on 2019-02-25. Applicant: Spineart.

Clearance details

Applicant: Spineart
Product code: Code NKG
Advisory panel: Orthopedic
Date received: 2019-01-15
Decision date: 2019-02-25
Decision: Substantially Equivalent
Clearance type: Special
Location: Plan Les Ouates, CH

Download summary PDF View on FDA.gov ↗

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.