Cleared Special

BIOANCHOR WITH DISPOSABLE DRIVER, PRELOADED WITH ONE #2 HERCULINE SUTURE

K042778 · Linvatec Corp. · Orthopedic
Nov 2004
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K042778 is an FDA 510(k) clearance for the BIOANCHOR WITH DISPOSABLE DRIVER, PRELOADED WITH ONE #2 HERCULINE SUTURE, a Screw, Fixation, Bone (Class II — Special Controls, product code HWC), submitted by Linvatec Corp. (Largo, US). The FDA issued a Cleared decision on November 4, 2004, 29 days after receiving the submission on October 6, 2004. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K042778 FDA.gov
FDA Decision Cleared SESE
Date Received October 06, 2004
Decision Date November 04, 2004
Days to Decision 29 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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