Cleared Traditional

BIOMET GRAFT DELIVERY SYRINGES

K140710 · Biomet Spine (Aka Ebi, LLC) · General Hospital
Sep 2014
Decision
167d
Days
Class 2
Risk

About This 510(k) Submission

K140710 is an FDA 510(k) clearance for the BIOMET GRAFT DELIVERY SYRINGES, a Syringe, Piston (Class II — Special Controls, product code FMF), submitted by Biomet Spine (Aka Ebi, LLC) (Parsippany, US). The FDA issued a Cleared decision on September 4, 2014, 167 days after receiving the submission on March 21, 2014. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5860.

Submission Details

510(k) Number K140710 FDA.gov
FDA Decision Cleared SESE
Date Received March 21, 2014
Decision Date September 04, 2014
Days to Decision 167 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code FMF — Syringe, Piston
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5860

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