Uni-FuZe-C Bone Strip— 510(k) K221726

Substantially Equivalent

Zavation Medical Products, LLC

FDA 510(k) clearance K221726 for Uni-FuZe-C Bone Strip, Substantially Equivalent on 2023-01-18. Applicant: Zavation Medical Products, LLC.

Clearance details

Applicant
Zavation Medical Products, LLC
Product code
Code MQV
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Flowood, MS, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code MQV

product code MQV
Death
6
Injury
435
Total
441

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.