DeviceClearance

ROCCIA ALIF, ROCCIA TLIF— 510(k) K180963

Substantially Equivalent

Silony Medical GmbH

FDA 510(k) clearance K180963 for ROCCIA ALIF, ROCCIA TLIF, Substantially Equivalent on 2018-07-11. Applicant: Silony Medical GmbH.

Clearance details

Applicant
Silony Medical GmbH
Product code
Code MAX
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Leinfelden-Echterdingen, DE
Download summary PDFView on FDA.gov ↗

Adverse events under product code MAX

product code MAX
Death
13
Injury
1,305
Malfunction
2,885
Total
4,203

Source: openFDA MAUDE database, through . 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.