Product Code: MVA FDA class 2 21 CFR 882.5970

Orthosis, Cranial

Neurology

A Cranial Orthosis is a custom or prefabricated external head device used to reshape the skull of infants with positional plagiocephaly (flat head syndrome) or craniosynostosis by applying gentle, corrective pressure to redirect skull growth during the period of rapid cranial development. It is FDA Class 2, requiring 510(k) clearance, with product code MVA under 21 CFR 882.5970 in the Neurology specialty. The device is not an implant and is not life-sustaining.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: MVA
Device Class: FDA class 2
Regulation Number: 882.5970
Medical Specialty: Neurology
Review Panel: NE
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 43 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K241957	Talee, Talee PostOp	Aug 30, 2024	Substantially Equivalent	Invent Medical USA, LLC
K230444	Talee, Talee PostOp	Jun 22, 2023	Substantially Equivalent	Invent Medical USA, LLC
K223238	STARband 3D	Apr 20, 2023	Substantially Equivalent	Orthomerica Products, Inc.
K220681	Talee, Talee PostOP	Sep 22, 2022	Substantially Equivalent	Invent Medical USA, LLC
K203134	Hanger Cranial Band 3D	Jul 01, 2022	Substantially Equivalent	Symbion Logistics, LLC
K213587	MyCRO Band	Jun 09, 2022	Substantially Equivalent	Otto Bock Healthcare LP
K193383	SnugKap	Jun 07, 2021	Substantially Equivalent	Headstart, Ltd.
K201426	MyCRO Band	Mar 26, 2021	Substantially Equivalent	Otto Bock Healthcare LP
K180568	KidCap	Oct 16, 2018	Substantially Equivalent	Eastern Cranial Affiliates, LLC
K141842	STARBAND, STARLIGHT	Oct 06, 2014	Substantially Equivalent	Orthomerica Products, Inc.
K140353	STARBAND AND STARLIGHT	Jun 06, 2014	Substantially Equivalent	Orthomerica Products, Inc.
K133397	P-POD	Apr 18, 2014	Substantially Equivalent	P-Pod
K111609	BOSTON BAND	Aug 22, 2011	Substantially Equivalent	Boston Brace Intl., Inc.
K111247	CRANIAL REMOLDING ORTHOSIS	Aug 15, 2011	Substantially Equivalent	Orthotic Care Services, Llp
K103362	AOI CRANIAL HELMET	Apr 18, 2011	Substantially Equivalent	Advanced Orthopro, Inc.
K090341	MICHIGAN CRANIAL RESHAPING ORTHOSIS	Jan 06, 2010	Substantially Equivalent	Danmar Products, Inc.
K070694	CCRO (CRANIOCEPHALIC CUSTOM REMOLDING ORTHOSIS)	Sep 10, 2007	Substantially Equivalent	Mike Miner
K063133	CRANIAL SOLUTION ORTHOSIS	Jul 02, 2007	Substantially Equivalent	Cranial Solutions
K063395	O&P BIVALVE CRANIAL MOLDING HELMET	Dec 22, 2006	Substantially Equivalent	Orthotic & Prosthetic Lab, Inc.
K042385	DOC BAND-POSTOP	Dec 17, 2004	Substantially Equivalent	Cranial Technologies, Inc.
K041215	CRANIAL HELMET	Sep 09, 2004	Substantially Equivalent	Otto Bock Healthcare LP
K021594	COPC BAND	Nov 13, 2003	Substantially Equivalent	Center For Orthotic and Prosthetic Care,Llc
K013452	DANMAR PRODUCTS CRANIAL ADJUSTIVE PROSTHESIS	Oct 31, 2003	Substantially Equivalent	Danmar Products, Inc.
K030669	PROVIDENCE MOLDING HELMET	Jul 18, 2003	Substantially Equivalent	Northeast Orthotics and Prothetics, Inc.
K023572	LOMA LINDA UNIVERSITY MEDICAL CENTER (LLUMC) CRANIAL REMOLDING HELMET	Jan 13, 2003	Substantially Equivalent	Rehabilitation Institute,Loma Linda University Med
K022273	CRANIAL SYMMETRY SYSTEM	Sep 09, 2002	Substantially Equivalent	Beverly Hills Prosthetics Orthotics, Inc.
K021221	O&P CRANICAL MOLDING HELMET	Jul 01, 2002	Substantially Equivalent	Orthotic & Prosthetic Lab, Inc.
K020448	STATIC CRANIOPLASTY ORTHOSIS	Apr 12, 2002	Substantially Equivalent	Eastern Cranial Affiliates
K013719	BECKER BAND CRANIAL REMOLDING ORTHOSIS	Feb 05, 2002	Substantially Equivalent	Becker Orthopedic Appliance Co.
K013700	ORTHOSIS HELMET MOLDING	Feb 05, 2002	Substantially Equivalent	Precision Prosthetics & Orthotics, Inc.
K012804	PLAGIOCEPHALIC APPLIED PRESSURE ORTHOSIS P.A.P. ORTHOSIS	Jan 17, 2002	Substantially Equivalent	Scott E Allen CP
K012920	MOLDED CRANIAL HELMET	Nov 28, 2001	Substantially Equivalent	Fairview Orthopedic Laboratory
K012830	LERMAN & SON CRANIAL ORTHOSIS HELMET	Nov 20, 2001	Substantially Equivalent	Lerman & Son
K013458	CRANIAL HELMET	Oct 29, 2001	Substantially Equivalent	Children'S Hospital
K012007	RHS HELMET	Sep 19, 2001	Substantially Equivalent	Restorative Health Svs, Inc.
K011433	BALLERT CRANIAL MOLDING HELMET	Jun 12, 2001	Substantially Equivalent	Gema, Inc.
K003035	CLARREN HELMET	Jun 06, 2001	Substantially Equivalent	Children'S Hospital & Medical Center
K003630	DANMAR PRODUCTS MICHIGAN CRANIAL HELMET	May 29, 2001	Substantially Equivalent	Danmar Products, Inc.
K010273	CRANIAL MOLDING ORTHOSIS	Apr 25, 2001	Substantially Equivalent	Orthotic Solutions, Inc.
K001669	HANGER CRANIAL BAND	Dec 08, 2000	Substantially Equivalent	Hanger Orthopedic Group, Inc.
K000861	CRANIOCAP	Oct 30, 2000	Substantially Equivalent	Gillette Children'S Specialty Healthcare
K001167	OPI BAND	Jul 07, 2000	Substantially Equivalent	Orthomerica Products, Inc.
DEN980001	DYNAMIC ORTHOTIC CRANIOPLASTY BAND; DOC BAND	May 29, 1998	Unknown	Cranial Technologies, Inc.