ALLOFUSE GEL AND PUTTY— 510(k) K071849

Name: FDA 510(k) clearance K071849
Creator: U.S. Food and Drug Administration
Published: 2008-12-04

Substantially Equivalent

Allosource, Inc.

FDA 510(k) clearance K071849 for ALLOFUSE GEL AND PUTTY, Substantially Equivalent on 2008-12-04. Applicant: Allosource, Inc.. Device class: 2.

Clearance details

Applicant: Allosource, Inc.
Product code: Code MQV
Device class: Class 2
Regulation: 21 CFR 888.3045
Advisory panel: Orthopedic
Date received: 2007-07-05
Decision date: 2008-12-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Centennial, CO, US

Download summary PDF View on FDA.gov ↗

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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 →

Recalls naming K071849

K-number listed on FDA's recall record

Z-1562-2014 — AlloFuse DBM Putty 5cc, Catalog No. 90038005 AlloFuse is indicated for orthopedic applications as filler for gaps or voids that are not intrinsic to the stability of the bony structure. AlloFuse is indicated to be packed gently into bony gaps in the skeletal system as a bone graft extender.Class II·Terminated·AlloSource, Inc.·20140325

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K071849.

Data sourced from openFDA. This site is unofficial and independent of the FDA.