Expedium Spine System, VIPER and VIPER 2 Systems— 510(k) K160904

Substantially Equivalent

Medos International SARL

FDA 510(k) clearance K160904 for Expedium Spine System, VIPER and VIPER 2 Systems, Substantially Equivalent on 2016-07-01. Applicant: Medos International SARL.

Clearance details

Applicant: Medos International SARL
Product code: Code NKB
Advisory panel: Orthopedic
Date received: 2016-04-01
Decision date: 2016-07-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Le Locle, CH

Download summary PDF View on FDA.gov ↗

Adverse events under product code NKB

product code NKB

Death: 27
Injury: 5,033
Malfunction: 4,140
Total: 9,200

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.