NORIAN DRILLABLE INJECT, NORIAN DRILLABLE FAST SET PUTTY— 510(k) K102722

Substantially Equivalent

Synthes USA Products, LLC

FDA 510(k) clearance K102722 for NORIAN DRILLABLE INJECT, NORIAN DRILLABLE FAST SET PUTTY, Substantially Equivalent on 2011-01-27. Applicant: Synthes USA Products, LLC.

Clearance details

Applicant: Synthes USA Products, LLC
Product code: Code MQV
Advisory panel: Orthopedic
Date received: 2010-09-21
Decision date: 2011-01-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West Chester, PA, US

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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.