ACTIFUSE BONE GRAFT SUBSTITUTE, ACTIFUSE MICROGRANULES BONE GRAFT SUBSTITUTE— 510(k) K090850

Name: FDA 510(k) clearance K090850
Creator: U.S. Food and Drug Administration
Published: 2009-07-30

Substantially Equivalent

Apatech , Ltd.

FDA 510(k) clearance K090850 for ACTIFUSE BONE GRAFT SUBSTITUTE, ACTIFUSE MICROGRANULES BONE GRAFT SUBSTITUTE, Substantially Equivalent on 2009-07-30. Applicant: Apatech , Ltd.. Device class: 2.

Clearance details

Applicant: Apatech , Ltd.
Product code: Code LYC
Device class: Class 2
Regulation: 21 CFR 872.3930
Advisory panel: Dental
Date received: 2009-03-30
Decision date: 2009-07-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Oregon City, OR, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K090850

K-number listed on FDA's recall record

Z-1922-2016 — Actifuse ABX/Actifuse MIS System A bone void filler intended only for orthopedic applications as a filler for gaps and voids that are not intrinsic to the stability of the bony structure.Class II·Terminated·Apatech Limited·20150818

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K090850.

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