0.5cc NanoFUSE, 1.0cc NanoFUSE, 2cc NanoFUSE, 5cc NanoFUSE, 10cc NanoFUSE— 510(k) K161996

Substantially Equivalent

Amend Surgical, Inc.

FDA 510(k) clearance K161996 for 0.5cc NanoFUSE, 1.0cc NanoFUSE, 2cc NanoFUSE, 5cc NanoFUSE, 10cc NanoFUSE, Substantially Equivalent on 2017-02-16. Applicant: Amend Surgical, Inc..

Clearance details

Applicant: Amend Surgical, Inc.
Product code: Code MQV
Advisory panel: Orthopedic
Date received: 2016-07-19
Decision date: 2017-02-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Alachua, FL, 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.