NEOTIS; NEOTIS 50— 510(k) K130953

Substantially Equivalent

Sbm Sciences For Bio Materials

FDA 510(k) clearance K130953 for NEOTIS; NEOTIS 50, Substantially Equivalent on 2013-07-15. Applicant: Sbm Sciences For Bio Materials.

Clearance details

Applicant: Sbm Sciences For Bio Materials
Product code: Code MQV
Advisory panel: Orthopedic
Date received: 2013-04-05
Decision date: 2013-07-15
Decision: Substantially Equivalent
Clearance type: Special
Location: Lourdes, FR

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.