Cleared Traditional

PROSTEP? TBI? (Tailors Bunion Implant) System

K190970 · Wrightmedicaltechnologyinc · Orthopedic
Aug 2019
Decision
123d
Days
Class 2
Risk

About This 510(k) Submission

K190970 is an FDA 510(k) clearance for the PROSTEP? TBI? (Tailors Bunion Implant) System, a Screw, Fixation, Bone (Class II — Special Controls, product code HWC), submitted by Wrightmedicaltechnologyinc (Memphis, US). The FDA issued a Cleared decision on August 13, 2019, 123 days after receiving the submission on April 12, 2019. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K190970 FDA.gov
FDA Decision Cleared SESE
Date Received April 12, 2019
Decision Date August 13, 2019
Days to Decision 123 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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