Cleared Traditional

TiTHON Staple with OsseoTi Technology

K151615 · Biomet Manufacturing Corp · Orthopedic
Oct 2015
Decision
109d
Days
Class 2
Risk

About This 510(k) Submission

K151615 is an FDA 510(k) clearance for the TiTHON Staple with OsseoTi Technology, a Staple, Fixation, Bone (Class II — Special Controls, product code JDR), submitted by Biomet Manufacturing Corp (Warsaw, US). The FDA issued a Cleared decision on October 2, 2015, 109 days after receiving the submission on June 15, 2015. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K151615 FDA.gov
FDA Decision Cleared SESE
Date Received June 15, 2015
Decision Date October 02, 2015
Days to Decision 109 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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