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 Cranial orthosis Cranial orthosis Cranial orthosis Cranial orthosis Cranial orthosis Cranial orthosis Cranial orthosis Cranial orthosis Cranial orthosis Cranial orthosis Cranial orthosis Cranial orthosis Cranial orthosis Cranial orthosis Cranial orthosis 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