STARband® 3D 765.10A

GUDID B15176510A0

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.

ORTHOMERICA PRODUCTS, INC.

Cranial orthosis

• Primary Device ID: B15176510A0
• NIH Device Record Key: 88eaa214-48a3-4991-b7e8-809778f22a56
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: STARband® 3D
• Version Model Number: 765.10A
• Catalog Number: 765.10A
• Company DUNS: 604405373
• Company Name: ORTHOMERICA PRODUCTS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 18004466770
• Email: custserv@orthomerica.com
• Phone: 18004466770
• Email: custserv@orthomerica.com
• Phone: 18004466770
• Email: custserv@orthomerica.com
• Phone: 18004466770
• Email: custserv@orthomerica.com
• Phone: 18004466770
• Email: custserv@orthomerica.com
• Phone: 18004466770
• Email: custserv@orthomerica.com
• Phone: 18004466770
• Email: custserv@orthomerica.com
• Phone: 18004466770
• Email: custserv@orthomerica.com
• Phone: 18004466770
• Email: custserv@orthomerica.com
• Phone: 18004466770
• Email: custserv@orthomerica.com
• Phone: 18004466770
• Email: custserv@orthomerica.com
• Phone: 18004466770
• Email: custserv@orthomerica.com
• Phone: 18004466770
• Email: custserv@orthomerica.com
• Phone: 18004466770
• Email: custserv@orthomerica.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B15176510A0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K240466

FDA Product Code

• MVA: Orthosis, Cranial

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-10-25
• Device Publish Date: 2024-10-17

On-Brand Devices [STARband® 3D]

• B15170910A0: The STARband® 3D is a patient specific cranial orthosis that redirects the head growth to impro
• B15176610A0: The STARband® 3D is a patient specific cranial orthosis that redirects the head growth to impro
• B15176510A0: The STARband® 3D is a patient specific cranial orthosis that redirects the head growth to impro
• B15176410A0: The STARband® 3D is a patient specific cranial orthosis that redirects the head growth to impro
• B15176310A0: The STARband® 3D is a patient specific cranial orthosis that redirects the head growth to impro
• B15176210A0: The STARband® 3D is a patient specific cranial orthosis that redirects the head growth to impro