DEVICE: STARband® (B151709A0)
Device Identifier (DI) Information
STARband®
709A
In Commercial Distribution
709A
ORTHOMERICA PRODUCTS, INC.
709A
In Commercial Distribution
709A
ORTHOMERICA PRODUCTS, INC.
The STARband® 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® 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 a side opening design and is held in place by a Velcro® strap across the side opening.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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62265 | Cranial orthosis |
A custom-made helmet-like device intended to be worn on the head of an infant with an abnormal head shape (e.g., due to plagiocephaly, brachycephaly, scaphocephaly), or after craniosynostosis repair surgery, to apply pressure to the cranium and improve cranial symmetry/shape during growth over a period of months. It is made of durable materials (e.g., plastic, solid foam) and is designed with patient-specific characteristics (e.g., size, shape) based on head measurements (e.g., clinical pictures, 3-D scans, casts). It is typically worn during daily activities and sleep. This is a single-patient device that can be reapplied during the treatment period (reusable) before being discarded.
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FDA Product Code
[?]Product Code | Product Code Name |
---|---|
OAN | Orthosis, Cranial, Laser Scan |
MVA | Orthosis, Cranial |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K011350 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
70b85673-b3eb-4da6-babe-f2665fc07e3d
July 06, 2018
3
August 23, 2016
July 06, 2018
3
August 23, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
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Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
18004466770
custserv@orthomerica.com
custserv@orthomerica.com