Cleared Traditional

ORTHOLOC? 2 Lapidus with Rotation System

K190670 · Wrightmedicaltechnologyinc · Orthopedic
May 2019
Decision
60d
Days
Class 2
Risk

About This 510(k) Submission

K190670 is an FDA 510(k) clearance for the ORTHOLOC? 2 Lapidus with Rotation System, a Plate, Fixation, Bone (Class II — Special Controls, product code HRS), submitted by Wrightmedicaltechnologyinc (Memphis, US). The FDA issued a Cleared decision on May 14, 2019, 60 days after receiving the submission on March 15, 2019. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K190670 FDA.gov
FDA Decision Cleared SESE
Date Received March 15, 2019
Decision Date May 14, 2019
Days to Decision 60 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code HRS — Plate, Fixation, Bone
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3030

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