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FDA 510(k)

STARband 3D

K-Number: K240466 · 2024-03-15

ApplicantOrthomerica Products, Inc.
Decision Date2024-03-15
Product CodeOAN
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

STARband 3D is a medical device manufactured by Orthomerica Products, Inc.. It received FDA 510(k) clearance on 2024-03-15 under approval number K240466. The device is classified under product code OAN. 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 2024-03-15. It is manufactured by Orthomerica Products, Inc.. The 510(k) number is K240466.

When was STARband 3D approved by the FDA?

STARband 3D received FDA 510(k) clearance on 2024-03-15, under approval number K240466.

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 OAN.

Other Devices by Orthomerica Products, Inc.

K161138St. Louis Band K180109STARband, STARlight, St. Louis Band K211376STARband K203098STARband, STARlight, St. Louis Band K223238STARband 3D

Related Devices (Code: OAN)

K161138St. Louis BandOrthomerica Products, Inc. K180109STARband, STARlight, St. Louis BandOrthomerica Products, Inc. K211376STARbandOrthomerica Products, Inc. K203098STARband, STARlight, St. Louis BandOrthomerica Products, Inc. K244056DOC Band 3DCranial Technologies, Inc.

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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