Product code MVA
- Device name
- Orthosis, Cranial
- Medical specialty
- Neurology
- Device class
- 2
- Regulation number
- 882.5970
- Review panel
- NE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K241957 | Talee, Talee PostOp | Invent Medical USA, LLC | 2024-08-30 |
| K230444 | Talee, Talee PostOp | Invent Medical USA, LLC | 2023-06-22 |
| K223238 | STARband 3D | Orthomerica Products, Inc. | 2023-04-20 |
| K220681 | Talee, Talee PostOP | Invent Medical USA, LLC | 2022-09-22 |
| K203134 | Hanger Cranial Band 3D | Symbion Logistics, LLC | 2022-07-01 |
| K213587 | MyCRO Band | Otto Bock Healthcare LP | 2022-06-09 |
| K193383 | SnugKap | Headstart, Ltd. | 2021-06-07 |
| K201426 | MyCRO Band | Otto Bock Healthcare LP | 2021-03-26 |
| K180568 | KidCap | Eastern Cranial Affiliates, LLC | 2018-10-16 |
| K141842 | STARBAND, STARLIGHT | Orthomerica Products, Inc. | 2014-10-06 |
| K140353 | STARBAND AND STARLIGHT | Orthomerica Products, Inc. | 2014-06-06 |
| K133397 | P-POD | P-Pod | 2014-04-18 |
| K111609 | BOSTON BAND | Boston Brace Intl., Inc. | 2011-08-22 |
| K111247 | CRANIAL REMOLDING ORTHOSIS | Orthotic Care Services, Llp | 2011-08-15 |
| K103362 | AOI CRANIAL HELMET | Advanced Orthopro, Inc. | 2011-04-18 |
| K090341 | MICHIGAN CRANIAL RESHAPING ORTHOSIS | Danmar Products, Inc. | 2010-01-06 |
| K070694 | CCRO (CRANIOCEPHALIC CUSTOM REMOLDING ORTHOSIS) | Mike Miner | 2007-09-10 |
| K063133 | CRANIAL SOLUTION ORTHOSIS | Cranial Solutions | 2007-07-02 |
| K063395 | O&P BIVALVE CRANIAL MOLDING HELMET | Orthotic & Prosthetic Lab, Inc. | 2006-12-22 |
| K042385 | DOC BAND-POSTOP | Cranial Technologies, Inc. | 2004-12-17 |
| K041215 | CRANIAL HELMET | Otto Bock Healthcare LP | 2004-09-09 |
| K021594 | COPC BAND | Center For Orthotic and Prosthetic Care,Llc | 2003-11-13 |
| K013452 | DANMAR PRODUCTS CRANIAL ADJUSTIVE PROSTHESIS | Danmar Products, Inc. | 2003-10-31 |
| K030669 | PROVIDENCE MOLDING HELMET | Northeast Orthotics and Prothetics, Inc. | 2003-07-18 |
| K023572 | LOMA LINDA UNIVERSITY MEDICAL CENTER (LLUMC) CRANIAL REMOLDING HELMET | Rehabilitation Institute,Loma Linda University Med | 2003-01-13 |
| K022273 | CRANIAL SYMMETRY SYSTEM | Beverly Hills Prosthetics Orthotics, Inc. | 2002-09-09 |
| K021221 | O&P CRANICAL MOLDING HELMET | Orthotic & Prosthetic Lab, Inc. | 2002-07-01 |
| K020448 | STATIC CRANIOPLASTY ORTHOSIS | Eastern Cranial Affiliates | 2002-04-12 |
| K013719 | BECKER BAND CRANIAL REMOLDING ORTHOSIS | Becker Orthopedic Appliance Co. | 2002-02-05 |
| K013700 | ORTHOSIS HELMET MOLDING | Precision Prosthetics & Orthotics, Inc. | 2002-02-05 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| B15176106A0 | STARband® Bi-Valve | ORTHOMERICA PRODUCTS, INC. | 2016-08-23 |
| B151763PA0 | STARband® | ORTHOMERICA PRODUCTS, INC. | 2016-08-23 |
| B151763A0 | STARband® | ORTHOMERICA PRODUCTS, INC. | 2016-08-23 |
| B15176308A0 | St. Louis Band | ORTHOMERICA PRODUCTS, INC. | 2016-08-23 |
| B15176307PA0 | STARlight® PRO | ORTHOMERICA PRODUCTS, INC. | 2016-08-23 |
| B15176306PA0 | STARband® Bi-Valve | ORTHOMERICA PRODUCTS, INC. | 2016-08-23 |
| B15176306A0 | STARband® Bi-Valve | ORTHOMERICA PRODUCTS, INC. | 2016-08-23 |
| B15176303PA0 | STARlight® | ORTHOMERICA PRODUCTS, INC. | 2016-08-23 |
| B15176303A0 | STARlight® | ORTHOMERICA PRODUCTS, INC. | 2016-08-23 |
| B15176301PA0 | STARlight® Bi-Valve | ORTHOMERICA PRODUCTS, INC. | 2016-08-23 |
| B15176301A0 | STARlight® Bi-Valve | ORTHOMERICA PRODUCTS, INC. | 2016-08-23 |
| B151761PA0 | STARband® | ORTHOMERICA PRODUCTS, INC. | 2016-08-23 |
| B151761A0 | STARband® | ORTHOMERICA PRODUCTS, INC. | 2016-08-23 |
| B15176107PA0 | STARlight® PRO | ORTHOMERICA PRODUCTS, INC. | 2016-08-23 |
| B15176106PA0 | STARband® Bi-Valve | ORTHOMERICA PRODUCTS, INC. | 2016-08-23 |
| B15170901A0 | STARlight® Bi-Valve | ORTHOMERICA PRODUCTS, INC. | 2016-08-23 |
| B15176103PA0 | STARlight® | ORTHOMERICA PRODUCTS, INC. | 2016-08-23 |
| B15176103A0 | STARlight® | ORTHOMERICA PRODUCTS, INC. | 2016-08-23 |
| B15176101PA0 | STARlight® Bi-Valve | ORTHOMERICA PRODUCTS, INC. | 2016-08-23 |
| B15176101A0 | STARlight® Bi-Valve | ORTHOMERICA PRODUCTS, INC. | 2016-08-23 |
| B151709PA0 | STARband® | ORTHOMERICA PRODUCTS, INC. | 2016-08-23 |
| B151709A0 | STARband® | ORTHOMERICA PRODUCTS, INC. | 2016-08-23 |
| B15170908PA0 | St. Louis Band | ORTHOMERICA PRODUCTS, INC. | 2016-08-23 |
| B15170907PA0 | STARlight® PRO | ORTHOMERICA PRODUCTS, INC. | 2016-08-23 |
| B15170906PA0 | STARband® Bi-Valve | ORTHOMERICA PRODUCTS, INC. | 2016-08-23 |
| B15170906A0 | STARband® Bi-Valve | ORTHOMERICA PRODUCTS, INC. | 2016-08-23 |
| B15170905A0 | Clarren Helmet | ORTHOMERICA PRODUCTS, INC. | 2016-08-23 |
| B15170903PA0 | STARlight® | ORTHOMERICA PRODUCTS, INC. | 2016-08-23 |
| B15170903A0 | STARlight® | ORTHOMERICA PRODUCTS, INC. | 2016-08-23 |
| B15170901PA0 | STARlight® Bi-Valve | ORTHOMERICA PRODUCTS, INC. | 2016-08-23 |