Cleared Traditional

TRICOS A RESORBABLE BONE SUBSTITUTE

K081717 · Baxter Healthcare Corp · Orthopedic
Oct 2008
Decision
114d
Days
Class 2
Risk

About This 510(k) Submission

K081717 is an FDA 510(k) clearance for the TRICOS A RESORBABLE BONE SUBSTITUTE, a Filler, Bone Void, Calcium Compound (Class II — Special Controls, product code MQV), submitted by Baxter Healthcare Corp (Mcgaw Park, US). The FDA issued a Cleared decision on October 10, 2008, 114 days after receiving the submission on June 18, 2008. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3045.

Submission Details

510(k) Number K081717 FDA.gov
FDA Decision Cleared SESE
Date Received June 18, 2008
Decision Date October 10, 2008
Days to Decision 114 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code MQV — Filler, Bone Void, Calcium Compound
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3045

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