Cleared Traditional

Tyber Medical BioTy(TM) Nanotopography Trauma Screw, TyFix Screw

K170571 · Tyber Medical, LLC · Orthopedic
Jun 2017
Decision
113d
Days
Class 2
Risk

About This 510(k) Submission

K170571 is an FDA 510(k) clearance for the Tyber Medical BioTy(TM) Nanotopography Trauma Screw, TyFix Screw, a Screw, Fixation, Bone (Class II — Special Controls, product code HWC), submitted by Tyber Medical, LLC (Bethlehem, US). The FDA issued a Cleared decision on June 20, 2017, 113 days after receiving the submission on February 27, 2017. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K170571 FDA.gov
FDA Decision Cleared SESE
Date Received February 27, 2017
Decision Date June 20, 2017
Days to Decision 113 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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