Cleared Special

INTEGRA BONE FIXATION SYSTEM

K050492 · Integra Lifesciences Corp. · Orthopedic
Mar 2005
Decision
14d
Days
Class 2
Risk

About This 510(k) Submission

K050492 is an FDA 510(k) clearance for the INTEGRA BONE FIXATION SYSTEM, a Plate, Fixation, Bone (Class II — Special Controls, product code HRS), submitted by Integra Lifesciences Corp. (Planisboro, US). The FDA issued a Cleared decision on March 14, 2005, 14 days after receiving the submission on February 28, 2005. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K050492 FDA.gov
FDA Decision Cleared SESE
Date Received February 28, 2005
Decision Date March 14, 2005
Days to Decision 14 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code HRS — Plate, Fixation, Bone
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3030

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