STARlight® Bi-Valve 766.01PA

GUDID B15176601PA0

The STARlight® 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 STARlight® Bi-Valve is made of clear Surlyn plastic or clear co-polyester plastic and may contain optional Aliplast foam (closed cell polyethylene) padding. 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: B15176601PA0
• NIH Device Record Key: 00008538-ad9d-426d-9801-e64694f698ee
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: STARlight® Bi-Valve
• Version Model Number: 766.01PA
• Catalog Number: 766.01PA
• 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	B15176601PA0 [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 [STARlight® Bi-Valve]

• B15176501PA0: The STARlight® Bi-Valve is a patient specific cranial orthosis that redirects the head growth t
• B15176501A0: The STARlight® Bi-Valve is a patient specific cranial orthosis that redirects the head growth t
• B15176401PA0: The STARlight® Bi-Valve is a patient specific cranial orthosis that redirects the head growth t
• B15176401A0: The STARlight® Bi-Valve is a patient specific cranial orthosis that redirects the head growth t
• B15176301PA0: The STARlight® Bi-Valve is a patient specific cranial orthosis that redirects the head growth t
• B15176301A0: The STARlight® Bi-Valve is a patient specific cranial orthosis that redirects the head growth t
• B15176201PA0: The STARlight® Bi-Valve is a patient specific cranial orthosis that redirects the head growth t
• B15176201A0: The STARlight® Bi-Valve is a patient specific cranial orthosis that redirects the head growth t
• B15176101PA0: The STARlight® Bi-Valve is a patient specific cranial orthosis that redirects the head growth t
• B15176101A0: The STARlight® Bi-Valve is a patient specific cranial orthosis that redirects the head growth t
• B15176001PA0: The STARlight® Bi-Valve is a patient specific cranial orthosis that redirects the head growth t
• B15176001A0: The STARlight® Bi-Valve is a patient specific cranial orthosis that redirects the head growth t
• B15170901PA0: The STARlight® Bi-Valve is a patient specific cranial orthosis that redirects the head growth t
• B15170901A0: The STARlight® Bi-Valve is a patient specific cranial orthosis that redirects the head growth t
• B15170401PA0: The STARlight® Bi-Valve is a patient specific cranial orthosis that redirects the head growth t
• B15170401A0: The STARlight® Bi-Valve is a patient specific cranial orthosis that redirects the head growth t
• B15170301PA0: The STARlight® Bi-Valve is a patient specific cranial orthosis that redirects the head growth t
• B15170301A0: The STARlight® Bi-Valve is a patient specific cranial orthosis that redirects the head growth t
• B15176601PA0: The STARlight® Bi-Valve is a patient specific cranial orthosis that redirects the head growth t
• B15176601A0: The STARlight® Bi-Valve is a patient specific cranial orthosis that redirects the head growth t