Elite SPK, Compasso, Elite SPK Kit— 510(k) K160500

Substantially Equivalent

Ncs Lab Srl

FDA 510(k) clearance K160500 for Elite SPK, Compasso, Elite SPK Kit, Substantially Equivalent on 2016-04-20. Applicant: Ncs Lab Srl.

Clearance details

Applicant: Ncs Lab Srl
Product code: Code MBI
Advisory panel: Orthopedic
Date received: 2016-02-23
Decision date: 2016-04-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carpi, MO, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code MBI

product code MBI

Injury: 3,163
Malfunction: 13,006
Other: 2
Total: 16,171

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.