Cleared Traditional

SALVATION Midfoot Nail

K180024 · Wrightmedicaltechnologyinc · Orthopedic
Jul 2018
Decision
189d
Days
Class 2
Risk

About This 510(k) Submission

K180024 is an FDA 510(k) clearance for the SALVATION Midfoot Nail, a Screw, Fixation, Bone (Class II — Special Controls, product code HWC), submitted by Wrightmedicaltechnologyinc (Memphis, US). The FDA issued a Cleared decision on July 11, 2018, 189 days after receiving the submission on January 3, 2018. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K180024 FDA.gov
FDA Decision Cleared SESE
Date Received January 03, 2018
Decision Date July 11, 2018
Days to Decision 189 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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