Cleared Traditional

NB3D BONE VOID FILLER

K111944 · Pioneer Surgical Technology, Inc. · Orthopedic
Nov 2011
Decision
137d
Days
Class 2
Risk

About This 510(k) Submission

K111944 is an FDA 510(k) clearance for the NB3D BONE VOID FILLER, a Filler, Bone Void, Calcium Compound (Class II — Special Controls, product code MQV), submitted by Pioneer Surgical Technology, Inc. (San Diego, US). The FDA issued a Cleared decision on November 22, 2011, 137 days after receiving the submission on July 8, 2011. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3045.

Submission Details

510(k) Number K111944 FDA.gov
FDA Decision Cleared SESE
Date Received July 08, 2011
Decision Date November 22, 2011
Days to Decision 137 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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