Cleared Special

BIOANCHOR WITH DISPOSABLE DRIVER

K033804 · Linvatec Corp. · Orthopedic
Dec 2003
Decision
23d
Days
Class 2
Risk

About This 510(k) Submission

K033804 is an FDA 510(k) clearance for the BIOANCHOR WITH DISPOSABLE DRIVER, a Screw, Fixation, Bone (Class II — Special Controls, product code HWC), submitted by Linvatec Corp. (Largo, US). The FDA issued a Cleared decision on December 31, 2003, 23 days after receiving the submission on December 8, 2003. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K033804 FDA.gov
FDA Decision Cleared SESE
Date Received December 08, 2003
Decision Date December 31, 2003
Days to Decision 23 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code HWC — Screw, Fixation, Bone
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3040

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