STARband® Bi-Valve 766.06A

GUDID B15176606A0

The STARband® Bi-Valve 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® Bi-Valve 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 an overlapping bi-valve design with a sliding mechanism and is held in place by a Velcro® strap.

ORTHOMERICA PRODUCTS, INC.

Cranial orthosis

• Primary Device ID: B15176606A0
• NIH Device Record Key: b779b697-0249-47dc-b798-a71ff4ddbf77
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: STARband® Bi-Valve
• Version Model Number: 766.06A
• Catalog Number: 766.06A
• 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: true
• 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
• 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	B15176606A0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151147

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: 2023-07-07
• Device Publish Date: 2023-06-29

On-Brand Devices [STARband® Bi-Valve]

• B15176506PA0: The STARband® Bi-Valve is a patient specific cranial orthosis that redirects the head growth to
• B15176506A0: The STARband® Bi-Valve is a patient specific cranial orthosis that redirects the head growth to
• B15176406PA0: The STARband® Bi-Valve is a patient specific cranial orthosis that redirects the head growth to
• B15176406A0: The STARband® Bi-Valve is a patient specific cranial orthosis that redirects the head growth to
• B15176306PA0: The STARband® Bi-Valve is a patient specific cranial orthosis that redirects the head growth to
• B15176306A0: The STARband® Bi-Valve is a patient specific cranial orthosis that redirects the head growth to
• B15176206PA0: The STARband® Bi-Valve is a patient specific cranial orthosis that redirects the head growth to
• B15176206A0: The STARband® Bi-Valve is a patient specific cranial orthosis that redirects the head growth to
• B15176106PA0: The STARband® Bi-Valve is a patient specific cranial orthosis that redirects the head growth to
• B15176106A0: The STARband® Bi-Valve is a patient specific cranial orthosis that redirects the head growth to
• B15176006PA0: The STARband® Bi-Valve is a patient specific cranial orthosis that redirects the head growth to
• B15176006A0: The STARband® Bi-Valve is a patient specific cranial orthosis that redirects the head growth to
• B15170906PA0: The STARband® Bi-Valve is a patient specific cranial orthosis that redirects the head growth to
• B15170906A0: The STARband® Bi-Valve is a patient specific cranial orthosis that redirects the head growth to
• B15170406PA0: The STARband® Bi-Valve is a patient specific cranial orthosis that redirects the head growth to
• B15170406A0: The STARband® Bi-Valve is a patient specific cranial orthosis that redirects the head growth to
• B15170306PA0: The STARband® Bi-Valve is a patient specific cranial orthosis that redirects the head growth to
• B15170306A0: The STARband® Bi-Valve is a patient specific cranial orthosis that redirects the head growth to
• B15176606PA0: The STARband® Bi-Valve is a patient specific cranial orthosis that redirects the head growth to
• B15176606A0: The STARband® Bi-Valve is a patient specific cranial orthosis that redirects the head growth to