Cleared Traditional

IMBIBE NEEDLE

K140414 · Orthovita, Inc. · Orthopedic
Apr 2014
Decision
42d
Days
Class 1
Risk

About This 510(k) Submission

K140414 is an FDA 510(k) clearance for the IMBIBE NEEDLE, a Orthopedic Manual Surgical Instrument (Class I — General Controls, product code LXH), submitted by Orthovita, Inc. (Malvern, US). The FDA issued a Cleared decision on April 1, 2014, 42 days after receiving the submission on February 18, 2014. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.4540.

Submission Details

510(k) Number K140414 FDA.gov
FDA Decision Cleared SESE
Date Received February 18, 2014
Decision Date April 01, 2014
Days to Decision 42 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code LXH — Orthopedic Manual Surgical Instrument
Device Class Class I — General Controls
CFR Regulation 21 CFR 888.4540

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