OTELO LL— 510(k) K151104

Substantially Equivalent

Spineart

FDA 510(k) clearance K151104 for OTELO LL, Substantially Equivalent on 2016-01-06. Applicant: Spineart.

Clearance details

Applicant: Spineart
Product code: Code GAD
Advisory panel: General, Plastic Surgery
Date received: 2015-04-24
Decision date: 2016-01-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Geneva, CH

Download summary PDF View on FDA.gov ↗

Adverse events under product code GAD

product code GAD

Malfunction: 504
Total: 504

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.