FDA 510(k)

Hanger Cranial Band 3D

K-Number: K203134 · 2022-07-01

Decision Date2022-07-01

Product CodeMVA

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

Hanger Cranial Band 3D is the device name listed in this FDA 510(k) record. The listed applicant is Symbion Logistics, LLC. It received FDA 510(k) clearance on 2022-07-01 under 510(k) number K203134. The device is classified under product code MVA. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Hanger Cranial Band 3D?

Hanger Cranial Band 3D is a medical device that received FDA 510(k) clearance on 2022-07-01. The listed applicant is Symbion Logistics, LLC. The 510(k) number is K203134.

When did Hanger Cranial Band 3D receive FDA 510(k) clearance?

Hanger Cranial Band 3D received FDA 510(k) clearance on 2022-07-01, under 510(k) number K203134.

Who is the listed applicant for Hanger Cranial Band 3D?

The FDA 510(k) record lists Symbion Logistics, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Hanger Cranial Band 3D?

The FDA product code for Hanger Cranial Band 3D is MVA.

Related Devices (Code: MVA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K241957Talee, Talee PostOpInvent Medical USA, LLC K230444Talee, Talee PostOpInvent Medical USA, LLC K223238STARband 3DOrthomerica Products, Inc.K220681Talee, Talee PostOPInvent Medical USA, LLC K213587MyCRO BandOtto Bock Healthcare LP K193383SnugKapHeadstart, Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.