Uni-FuZe-C Bone Strip— 510(k) K221726

Name: FDA 510(k) clearance K221726
Creator: U.S. Food and Drug Administration
Published: 2023-01-18

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. Device class: 2.

Clearance details

Applicant: Zavation Medical Products, LLC
Product code: Code MQV
Device class: Class 2
Regulation: 21 CFR 888.3045
Advisory panel: Orthopedic
Date received: 2022-06-14
Decision date: 2023-01-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Flowood, MS, US

Download summary PDF View on FDA.gov ↗

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K261008 — Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip +7 more2026-04-24
K253524 — Adaptos®Fuse Bone Graft2026-02-17

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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.