STARband® Plus 763.09A

GUDID B15176309A0

The STARband® Plus 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.

ORTHOMERICA PRODUCTS, INC.

Cranial orthosis

• Primary Device ID: B15176309A0
• NIH Device Record Key: 082b5236-39f3-4cab-9ebb-e81b74ceccfd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: STARband® Plus
• Version Model Number: 763.09A
• Catalog Number: 763.09A
• 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	B15176309A0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211376

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® Plus]

• B15176609PA0: The STARband® Plus is a patient specific cranial orthosis that redirects the head growth to imp
• B15176609A0: The STARband® Plus is a patient specific cranial orthosis that redirects the head growth to imp
• B15176509PA0: The STARband® Plus is a patient specific cranial orthosis that redirects the head growth to imp
• B15176509A0: The STARband® Plus is a patient specific cranial orthosis that redirects the head growth to imp
• B15176409PA0: The STARband® Plus is a patient specific cranial orthosis that redirects the head growth to imp
• B15176409A0: The STARband® Plus is a patient specific cranial orthosis that redirects the head growth to imp
• B15176309PA0: The STARband® Plus is a patient specific cranial orthosis that redirects the head growth to imp
• B15176309A0: The STARband® Plus is a patient specific cranial orthosis that redirects the head growth to imp
• B15176209PA0: The STARband® Plus is a patient specific cranial orthosis that redirects the head growth to imp
• B15176209A0: The STARband® Plus is a patient specific cranial orthosis that redirects the head growth to imp
• B15176109PA0: The STARband® Plus is a patient specific cranial orthosis that redirects the head growth to imp
• B15176109A0: The STARband® Plus is a patient specific cranial orthosis that redirects the head growth to imp
• B15176009PA0: The STARband® Plus is a patient specific cranial orthosis that redirects the head growth to imp
• B15176009A0: The STARband® Plus is a patient specific cranial orthosis that redirects the head growth to imp
• B15170909PA0: The STARband® Plus is a patient specific cranial orthosis that redirects the head growth to imp
• B15170909A0: The STARband® Plus is a patient specific cranial orthosis that redirects the head growth to imp
• B15170409PA0: The STARband® Plus is a patient specific cranial orthosis that redirects the head growth to imp
• B15170409A0: The STARband® Plus is a patient specific cranial orthosis that redirects the head growth to imp
• B15170309PA0: The STARband® Plus is a patient specific cranial orthosis that redirects the head growth to imp
• B15170309A0: The STARband® Plus is a patient specific cranial orthosis that redirects the head growth to imp