NanoBone SBX Putty— 510(k) K161351

Substantially Equivalent

Artoss GmbH

FDA 510(k) clearance K161351 for NanoBone SBX Putty, Substantially Equivalent on 2016-10-26. Applicant: Artoss GmbH.

Clearance details

Applicant: Artoss GmbH
Product code: Code MQV
Advisory panel: Orthopedic
Date received: 2016-05-16
Decision date: 2016-10-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rostock, DE

Download summary PDF View on FDA.gov ↗

Adverse events under product code MQV

product code MQV

Death: 6
Injury: 435
Total: 441

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.