Cleared Traditional

K203134 - Hanger Cranial Band 3D
(FDA 510(k) Clearance)

K203134 · Symbion Logistics, LLC · Neurology
Jul 2022
Decision
620d
Days
Class 2
Risk

K203134 is an FDA 510(k) clearance for the Hanger Cranial Band 3D, a Orthosis, Cranial (Class II — Special Controls, product code MVA), submitted by Symbion Logistics, LLC (Tempe, US). The FDA issued a Cleared decision on July 1, 2022, 620 days after receiving the submission on October 19, 2020. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5970.

Submission Details

510(k) Number K203134 FDA.gov
FDA Decision Cleared SESE
Date Received October 19, 2020
Decision Date July 01, 2022
Days to Decision 620 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code MVA — Orthosis, Cranial
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.5970