STARband®

FDA UDI

Class II (US FDA UDI)

by Orthomerica Products, Inc.

Identity

Trade Name: STARband® FDA UDI
Generic Name: Cranial orthosis FDA UDI
Device Name: The STARband® 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. This device is also indicated for adjunctive use for infants from 3 to 18 months of age whose synostosis has been surgically corrected, but who still have moderate-to-severe cranial deformities including plagiocephalic-, brachycephalic- and scaphocephalic-shaped heads. The STARband® is made with an outer copolymer plastic shell and an inner liner made of pelite polyethylene foam or Aliplast foam (closed cell polyethylene). It utilizes a side opening design and is held in place by a Velcro® strap across the side opening. FDA UDI
Model / Reference: 764PA FDA UDI
Description: The STARband® 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. This device is also indicated for adjunctive use for infants from 3 to 18 months of age whose synostosis has been surgically corrected, but who still have moderate-to-severe cranial deformities including plagiocephalic-, brachycephalic- and scaphocephalic-shaped heads. The STARband® is made with an outer copolymer plastic shell and an inner liner made of pelite polyethylene foam or Aliplast foam (closed cell polyethylene). It utilizes a side opening design and is held in place by a Velcro® strap across the side opening. FDA UDI

Identifiers

Catalog Number: 764PA FDA UDI
Primary DI / UDI-DI: B151764PA0 FDA UDI
510(k) Number: K151147 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

Yes

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

Similar devices

Also classified as Cranial orthosis.

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MyCRO Band — OTTO BOCK HEALTHCARE · Class II
Boston Band — Boston Brace International, Inc. · Class II
Michigan Cranial Reshaping Orthosis — DANMAR PRODUCTS, INC. · Class II
Doc Band® — CRANIAL TECHNOLOGIES, INC. · Class II
MyCRO Band — OTTO BOCK HEALTHCARE · Class II
MyCRO Band — OTTO BOCK HEALTHCARE · Class II

Cleared under the same submission

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 ff15cb2c-28ae-4d0e-973a-2a52f95830fb 36 fields · synced May 30, 2026