FDA 510(k) Applications for Medical Device Product Code "MVA"
(Orthosis, Cranial)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K103362 | ADVANCED ORTHOPRO INC. | AOI CRANIAL HELMET | 04/18/2011 |
| K013719 | BECKER ORTHOPEDIC APPLIANCE CO. | BECKER BAND CRANIAL REMOLDING ORTHOSIS | 02/05/2002 |
| K022273 | BEVERLY HILLS PROSTHETICS ORTHOTICS, INC. | CRANIAL SYMMETRY SYSTEM | 09/09/2002 |
| K111609 | BOSTON BRACE INTL., INC. | BOSTON BAND | 08/22/2011 |
| K021594 | CENTER FOR ORTHOTIC AND PROSTHETIC CARE,LLC | COPC BAND | 11/13/2003 |
| K013458 | CHILDREN'S HOSPITAL | CRANIAL HELMET | 10/29/2001 |
| K003035 | CHILDREN'S HOSPITAL & MEDICAL CENTER | CLARREN HELMET | 06/06/2001 |
| K063133 | CRANIAL SOLUTIONS | CRANIAL SOLUTION ORTHOSIS | 07/02/2007 |
| K042385 | CRANIAL TECHNOLOGIES, INC. | DOC BAND-POSTOP | 12/17/2004 |
| DEN980001 | CRANIAL TECHNOLOGIES, INC. | DYNAMIC ORTHOTIC CRANIOPLASTY BAND; DOC BAND | 05/29/1998 |
| K013452 | DANMAR PRODUCTS, INC. | DANMAR PRODUCTS CRANIAL ADJUSTIVE PROSTHESIS | 10/31/2003 |
| K003630 | DANMAR PRODUCTS, INC. | DANMAR PRODUCTS MICHIGAN CRANIAL HELMET | 05/29/2001 |
| K090341 | DANMAR PRODUCTS, INC. | MICHIGAN CRANIAL RESHAPING ORTHOSIS | 01/06/2010 |
| K020448 | EASTERN CRANIAL AFFILIATES | STATIC CRANIOPLASTY ORTHOSIS | 04/12/2002 |
| K180568 | Eastern Cranial Affiliates, LLC | KidCap | 10/16/2018 |
| K012920 | FAIRVIEW ORTHOPEDIC LABORATORY | MOLDED CRANIAL HELMET | 11/28/2001 |
| K011433 | GEMA, INC. | BALLERT CRANIAL MOLDING HELMET | 06/12/2001 |
| K000861 | GILLETTE CHILDREN'S SPECIALTY HEALTHCARE | CRANIOCAP | 10/30/2000 |
| K001669 | HANGER ORTHOPEDIC GROUP, INC. | HANGER CRANIAL BAND | 12/08/2000 |
| K193383 | HeadStart, Ltd. | SnugKap | 06/07/2021 |
| K220681 | Invent Medical USA, LLC | Talee, Talee PostOP | 09/22/2022 |
| K230444 | Invent Medical USA, LLC | Talee, Talee PostOp | 06/22/2023 |
| K012830 | LERMAN & SON | LERMAN & SON CRANIAL ORTHOSIS HELMET | 11/20/2001 |
| K070694 | MIKE MINER | CCRO (CRANIOCEPHALIC CUSTOM REMOLDING ORTHOSIS) | 09/10/2007 |
| K030669 | NORTHEAST ORTHOTICS AND PROTHETICS, INC. | PROVIDENCE MOLDING HELMET | 07/18/2003 |
| K223238 | Orthomerica Products Inc. | STARband 3D | 04/20/2023 |
| K001167 | ORTHOMERICA PRODUCTS, INC. | OPI BAND | 07/07/2000 |
| K140353 | ORTHOMERICA PRODUCTS, INC. | STARBAND AND STARLIGHT | 06/06/2014 |
| K141842 | ORTHOMERICA PRODUCTS, INC. | STARBAND, STARLIGHT | 10/06/2014 |
| K063395 | ORTHOTIC & PROSTHETIC LAB, INC. | O&P BIVALVE CRANIAL MOLDING HELMET | 12/22/2006 |
| K021221 | ORTHOTIC & PROSTHETIC LAB, INC. | O&P CRANICAL MOLDING HELMET | 07/01/2002 |
| K111247 | ORTHOTIC CARE SERVICES, LLP | CRANIAL REMOLDING ORTHOSIS | 08/15/2011 |
| K010273 | ORTHOTIC SOLUTIONS, INC. | CRANIAL MOLDING ORTHOSIS | 04/25/2001 |
| K041215 | OTTO BOCK HEALTH CARE, LP | CRANIAL HELMET | 09/09/2004 |
| K201426 | Otto Bock Healthcare LP | MyCRO Band | 03/26/2021 |
| K213587 | Otto Bock Healthcare LP | MyCRO Band | 06/09/2022 |
| K133397 | P-POD | P-POD | 04/18/2014 |
| K013700 | PRECISION PROSTHETICS & ORTHOTICS, INC. | ORTHOSIS HELMET MOLDING | 02/05/2002 |
| K023572 | REHABILITATION INSTITUTE,LOMA LINDA UNIVERSITY MED | LOMA LINDA UNIVERSITY MEDICAL CENTER (LLUMC) CRANIAL REMOLDING HELMET | 01/13/2003 |
| K012007 | RESTORATIVE HEALTH SVS, INC. | RHS HELMET | 09/19/2001 |
| K012804 | SCOTT E ALLEN CP | PLAGIOCEPHALIC APPLIED PRESSURE ORTHOSIS P.A.P. ORTHOSIS | 01/17/2002 |
| K203134 | Symbion Logistics, LLC | Hanger Cranial Band 3D | 07/01/2022 |
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