Cleared Traditional

BIOSCREW XTRALOK

K013131 · Linvatec Corp. · Orthopedic
Jun 2002
Decision
265d
Days
Class 2
Risk

About This 510(k) Submission

K013131 is an FDA 510(k) clearance for the BIOSCREW XTRALOK, a Screw, Fixation, Bone (Class II — Special Controls, product code HWC), submitted by Linvatec Corp. (Largo, US). The FDA issued a Cleared decision on June 11, 2002, 265 days after receiving the submission on September 19, 2001. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K013131 FDA.gov
FDA Decision Cleared SESE
Date Received September 19, 2001
Decision Date June 11, 2002
Days to Decision 265 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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