Cleared Traditional

Xpert Wrist

K213214 · Newclip Technics · Orthopedic
Nov 2021
Decision
56d
Days
Class 2
Risk

About This 510(k) Submission

K213214 is an FDA 510(k) clearance for the Xpert Wrist, a Plate, Fixation, Bone (Class II — Special Controls, product code HRS), submitted by Newclip Technics (Haute-Goulaine, FR). The FDA issued a Cleared decision on November 24, 2021, 56 days after receiving the submission on September 29, 2021. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K213214 FDA.gov
FDA Decision Cleared SESE
Date Received September 29, 2021
Decision Date November 24, 2021
Days to Decision 56 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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