DUOWEDGE SYNTHETIC BONE SUBSTITUTE— 510(k) K073214

Name: FDA 510(k) clearance K073214
Creator: U.S. Food and Drug Administration
Published: 2009-12-01

Substantially Equivalent

Kasios

FDA 510(k) clearance K073214 for DUOWEDGE SYNTHETIC BONE SUBSTITUTE, Substantially Equivalent on 2009-12-01. Applicant: Kasios. Device class: 2.

Clearance details

Applicant: Kasios
Product code: Code MQV
Device class: Class 2
Regulation: 21 CFR 888.3045
Advisory panel: Orthopedic
Date received: 2007-11-14
Decision date: 2009-12-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Round Rock, TX, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code MQV

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K262230 — Mg OSTEOREVIVE; Mg OSTEOCRETE2026-09-11
K260364 — Device 300419 Strip2026-06-02
K252797 — JAZBI Resorbable Bone Void Filler2026-05-26
K261008 — Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip +7 more2026-04-24
K253524 — Adaptos®Fuse Bone Graft2026-02-17

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.