Cleared Traditional

PLEXUR M

K073405 · Osteotech, Inc. · Orthopedic
Mar 2008
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K073405 is an FDA 510(k) clearance for the PLEXUR M, a Filler, Bone Void, Calcium Compound (Class II — Special Controls, product code MQV), submitted by Osteotech, Inc. (Eatontown, US). The FDA issued a Cleared decision on March 3, 2008, 90 days after receiving the submission on December 4, 2007. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3045.

Submission Details

510(k) Number K073405 FDA.gov
FDA Decision Cleared SESE
Date Received December 04, 2007
Decision Date March 03, 2008
Days to Decision 90 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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