Cleared Traditional

PLEXUR P

K061982 · Osteotech, Inc. · Orthopedic
Feb 2007
Decision
209d
Days
Class 2
Risk

About This 510(k) Submission

K061982 is an FDA 510(k) clearance for the PLEXUR P, a Filler, Bone Void, Osteoinduction (w/o Human Growth Factor) (Class II — Special Controls, product code MBP), submitted by Osteotech, Inc. (Eatontown, US). The FDA issued a Cleared decision on February 7, 2007, 209 days after receiving the submission on July 13, 2006. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3045.

Submission Details

510(k) Number K061982 FDA.gov
FDA Decision Cleared SESE
Date Received July 13, 2006
Decision Date February 07, 2007
Days to Decision 209 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code MBP — Filler, Bone Void, Osteoinduction (w/o Human Growth Factor)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3045

Similar Devices — MBP Filler, Bone Void, Osteoinduction (w/o Human Growth Factor)

All 30
PliaFX Flo
K242799 · Lifenet Health · Nov 2024
Vivorte Trabexus EB
K143547 · Vivorte, Inc. · Jan 2015
VIVORTE BVF
K130703 · Vivorte, Inc. · Sep 2013
OSTEOSELECT DEMINERALIZED BONE MATRIX PUTTY
K130498 · Bacterin International, Inc. · May 2013
CLEARED UNDER GRAFTON II EDBM
K122513 · Medtronic Sofamor Danek, Inc. · Mar 2013
SURFUSE GEL AND PUTTY, EXFUSE GEL AND PUTTY
K113728 · Hans Biomed Corp. · Nov 2012