STARband® 3D

FDA UDI

Class II (US FDA UDI)

by Orthomerica Products, Inc.

Identity

Trade Name: STARband® 3D FDA UDI
Generic Name: Cranial orthosis FDA UDI
Device Name: The STARband® 3D is a patient specific cranial orthosis that redirects the head growth to improve proportion and symmetry. It is intended for use on infants from 3 to 18 months of age, with moderate-to-severe non-synostotic positional head shape deformities, including infants with plagiocephalic-, brachycephalic- and scaphocephalic-shaped heads by applying mild pressure to prominent regions of the infant's cranium in order to improve cranial symmetry and/or shape. FDA UDI
Model / Reference: 765.10A FDA UDI
Description: The STARband® 3D is a patient specific cranial orthosis that redirects the head growth to improve proportion and symmetry. It is intended for use on infants from 3 to 18 months of age, with moderate-to-severe non-synostotic positional head shape deformities, including infants with plagiocephalic-, brachycephalic- and scaphocephalic-shaped heads by applying mild pressure to prominent regions of the infant's cranium in order to improve cranial symmetry and/or shape. FDA UDI

Identifiers

Catalog Number: 765.10A FDA UDI
Primary DI / UDI-DI: B15176510A0 FDA UDI
510(k) Number: K240466 FDA UDI
FDA Product Code: MVA FDA UDI
OAN FDA UDI
GMDN Term: Cranial orthosis FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 882.5970 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Cranial orthosis

STARband® 3D by Orthomerica Products, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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MyCRO Band — OTTO BOCK HEALTHCARE · Class II

Cleared under the same submission

K240466 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Orthomerica Products, Inc.

Sources (1)

FDA UDI 88eaa214-48a3-4991-b7e8-809778f22a56 36 fields · synced May 30, 2026