Cleared Special

PRODENSE Bone Graft Substitute

K182823 · Wrightmedicaltechnologyinc · Orthopedic
Nov 2018
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K182823 is an FDA 510(k) clearance for the PRODENSE Bone Graft Substitute, a Filler, Bone Void, Calcium Compound (Class II — Special Controls, product code MQV), submitted by Wrightmedicaltechnologyinc (Memphis, US). The FDA issued a Cleared decision on November 2, 2018, 29 days after receiving the submission on October 4, 2018. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3045.

Submission Details

510(k) Number K182823 FDA.gov
FDA Decision Cleared SESE
Date Received October 04, 2018
Decision Date November 02, 2018
Days to Decision 29 days
Submission Type Special
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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