Cleared Traditional

Sterile PHALINX Hammertoe System

K212996 · Wrightmedicaltechnologyinc · Orthopedic
Nov 2021
Decision
57d
Days
Class 2
Risk

About This 510(k) Submission

K212996 is an FDA 510(k) clearance for the Sterile PHALINX Hammertoe System, a Screw, Fixation, Bone (Class II — Special Controls, product code HWC), submitted by Wrightmedicaltechnologyinc (Memphis, US). The FDA issued a Cleared decision on November 16, 2021, 57 days after receiving the submission on September 20, 2021. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K212996 FDA.gov
FDA Decision Cleared SESE
Date Received September 20, 2021
Decision Date November 16, 2021
Days to Decision 57 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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