Cleared Special

BIOSCREW XTRALOK, 8X35MM & 8X40MM VIOLET

K050497 · Linvatec Corp. · Orthopedic
Mar 2005
Decision
25d
Days
Class 2
Risk

About This 510(k) Submission

K050497 is an FDA 510(k) clearance for the BIOSCREW XTRALOK, 8X35MM & 8X40MM VIOLET, a Screw, Fixation, Bone (Class II — Special Controls, product code HWC), submitted by Linvatec Corp. (Largo, US). The FDA issued a Cleared decision on March 25, 2005, 25 days after receiving the submission on February 28, 2005. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K050497 FDA.gov
FDA Decision Cleared SESE
Date Received February 28, 2005
Decision Date March 25, 2005
Days to Decision 25 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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