Cleared Traditional

PRE-LOADED BIOSTINGER HORNET

K020377 · Linvatec Corp. · Orthopedic
May 2002
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K020377 is an FDA 510(k) clearance for the PRE-LOADED BIOSTINGER HORNET, a Screw, Fixation, Bone (Class II — Special Controls, product code HWC), submitted by Linvatec Corp. (Largo, US). The FDA issued a Cleared decision on May 6, 2002, 90 days after receiving the submission on February 5, 2002. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K020377 FDA.gov
FDA Decision Cleared SESE
Date Received February 05, 2002
Decision Date May 06, 2002
Days to Decision 90 days
Submission Type Traditional
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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