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FDA 510(k)

STARband 3D

K-Number: K223238 · 2023-04-20

ApplicantOrthomerica Products, Inc.
Decision Date2023-04-20
Product CodeMVA
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

STARband 3D is a medical device manufactured by Orthomerica Products, Inc.. It received FDA 510(k) clearance on 2023-04-20 under approval number K223238. 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 STARband 3D?

STARband 3D is a medical device that received FDA 510(k) clearance on 2023-04-20. It is manufactured by Orthomerica Products, Inc.. The 510(k) number is K223238.

When was STARband 3D approved by the FDA?

STARband 3D received FDA 510(k) clearance on 2023-04-20, under approval number K223238.

What company makes STARband 3D?

STARband 3D is manufactured by Orthomerica Products, Inc..

What is the FDA product code for STARband 3D?

The FDA product code for STARband 3D is MVA.

Other Devices by Orthomerica Products, Inc.

K161138St. Louis Band K180109STARband, STARlight, St. Louis Band K211376STARband K203098STARband, STARlight, St. Louis Band K240466STARband 3D

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Official Source

View on FDA Database →

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

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