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FDA-Approved Cranial Orthoses
Definition: a cranial orthosis is a medical device designed to apply pressure to the prominent regions of an infant's cranium, to improve the symmetry and/or shape the head.  Orthotic cranioplasty is correct of cranial asymmetry using this non-surgical device.

Provision of this listing is neither an endorsement nor a representation of a preference for any of the listed companies or products.

To exchange links, contact Kevin Kelly.  Be certain to include: a link to your approval on the FDA website, the name of your cranial orthosis, your company name, your company website URL, and the URL location of your reciprocal link to www.plagiocephaly.info.

Device Applicant 510k Approval Predicate
Dynamic Orthotic Cranioplasty Band; DOC Cranial Technologies, Inc. K964992 5/29/1998 No predicate. First FDA approved cranial orthosis
Opi Band Orthomerica Products K001167 7/7/2000 Cranial Technologies, Inc.'s DOC Band (K964992)
CranioCap Gillette Children's Hospital K000861 10/30/2000 Cranial Technologies, Inc.'s DOC Band (K964992)
Hanger Cranial Band Hanger Orthopedic Group, Inc. K001669 12/8/2000 Cranial Technologies, Inc.'s DOC Band (K964992)
Cranial Molding Orthosis Orthotic Solutions, Inc. K010273 4/25/2001 Cranial Technologies, Inc.'s DOC Band (K964992)
Danmar Products Michigan Cranial Helmet Danmar Products, Inc K003630 5/29/2001 Cranial Technologies, Inc.'s DOC Band (K964992)
Clarren Helmet Children's Hospital, Omaha, NE K003035 6/6/2001 NA
Ballert Cranial Molding Helmet GEMA, inc., Ballert Orthopedic K011433 6/12/2001 Substantially Equivalent (SE)
RHS Helmet Restorative Health Services, Inc. K012007 9/19/2001 Clarren Helmet (K003035)
Cranial Helmet Children's Hospital, Omaha, NE K013458 10/29/2001 CranioCap (K000861)
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Provision of this listing is neither an endorsement nor a representation of a preference for any of the listed companies or products.

To exchange links, contact Kevin Kelly.  Be certain to include: a link to your approval on the FDA website, the name of your cranial orthosis, your company name, your company website URL, and the URL location of your reciprocal link to www.plagiocephaly.info.

Last updated: 18-Apr-2008
 
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The information provided on this web site, although based on a thorough and careful review of the medical literature, is for educational purposes only and is not intended as a substitute for the medical advice of physicians. The reader should consult a physician in matters relating to health and particularly in regards to any symptoms which may require diagnosis or medical attention. Neither the author nor the publisher shall be responsible for any harm or injury resulting from interpretations of the materials in this site.
Plagiocephaly.Info, formerly Plagiocephaly.org.
Another Internet presence provided by Kelly Webworks.

For questions and/or comments about the this page, contact Kevin M. Kelly.

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