Cleared Traditional

Tyber Medical Staple Fixation System (various)

K221947 · Tyber Medical, LLC · Orthopedic
Oct 2022
Decision
107d
Days
Class 2
Risk

About This 510(k) Submission

K221947 is an FDA 510(k) clearance for the Tyber Medical Staple Fixation System (various), a Staple, Fixation, Bone (Class II — Special Controls, product code JDR), submitted by Tyber Medical, LLC (Bethlehem, US). The FDA issued a Cleared decision on October 20, 2022, 107 days after receiving the submission on July 5, 2022. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K221947 FDA.gov
FDA Decision Cleared SESE
Date Received July 05, 2022
Decision Date October 20, 2022
Days to Decision 107 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code JDR — Staple, Fixation, Bone
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3030

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