FDA Product Code
FDA Product Code MVA — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Neurology
- 21 CFR Citation
- 882.5970
510(k) Clearances — 43 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K241957 | Talee, Talee PostOp | Invent Medical USA, LLC | 2024-08-30 | Traditional | PDF ↗ |
| K230444 | Talee, Talee PostOp | Invent Medical USA, LLC | 2023-06-22 | Traditional | PDF ↗ |
| K223238 | STARband 3D | Orthomerica Products, Inc. | 2023-04-20 | Traditional | PDF ↗ |
| K220681 | Talee, Talee PostOP | Invent Medical USA, LLC | 2022-09-22 | Traditional | PDF ↗ |
| K203134 | Hanger Cranial Band 3D | Symbion Logistics, LLC | 2022-07-01 | Traditional | PDF ↗ |
| K213587 | MyCRO Band | Otto Bock Healthcare LP | 2022-06-09 | Traditional | PDF ↗ |
| K193383 | SnugKap | Headstart, Ltd. | 2021-06-07 | Traditional | PDF ↗ |
| K201426 | MyCRO Band | Otto Bock Healthcare LP | 2021-03-26 | Traditional | PDF ↗ |
| K180568 | KidCap | Eastern Cranial Affiliates, LLC | 2018-10-16 | Traditional | PDF ↗ |
| K141842 | STARBAND, STARLIGHT | Orthomerica Products, Inc. | 2014-10-06 | Traditional | PDF ↗ |
| K140353 | STARBAND AND STARLIGHT | Orthomerica Products, Inc. | 2014-06-06 | Traditional | PDF ↗ |
| K133397 | P-POD | P-Pod | 2014-04-18 | Traditional | PDF ↗ |
| K111609 | BOSTON BAND | Boston Brace Intl., Inc. | 2011-08-22 | Traditional | PDF ↗ |
| K111247 | CRANIAL REMOLDING ORTHOSIS | Orthotic Care Services, Llp | 2011-08-15 | Traditional | PDF ↗ |
| K103362 | AOI CRANIAL HELMET | Advanced Orthopro, Inc. | 2011-04-18 | Traditional | PDF ↗ |
| K090341 | MICHIGAN CRANIAL RESHAPING ORTHOSIS | Danmar Products, Inc. | 2010-01-06 | Traditional | PDF ↗ |
| K070694 | CCRO (CRANIOCEPHALIC CUSTOM REMOLDING ORTHOSIS) | Mike Miner | 2007-09-10 | Traditional | PDF ↗ |
| K063133 | CRANIAL SOLUTION ORTHOSIS | Cranial Solutions | 2007-07-02 | Traditional | PDF ↗ |
| K063395 | O&P BIVALVE CRANIAL MOLDING HELMET | Orthotic & Prosthetic Lab, Inc. | 2006-12-22 | Traditional | PDF ↗ |
| K042385 | DOC BAND-POSTOP | Cranial Technologies, Inc. | 2004-12-17 | Traditional | PDF ↗ |
| K041215 | CRANIAL HELMET | Otto Bock Healthcare LP | 2004-09-09 | Traditional | PDF ↗ |
| K021594 | COPC BAND | Center For Orthotic and Prosthetic Care,Llc | 2003-11-13 | Traditional | PDF ↗ |
| K013452 | DANMAR PRODUCTS CRANIAL ADJUSTIVE PROSTHESIS | Danmar Products, Inc. | 2003-10-31 | Traditional | PDF ↗ |
| K030669 | PROVIDENCE MOLDING HELMET | Northeast Orthotics and Prothetics, Inc. | 2003-07-18 | Abbreviated | PDF ↗ |
| K023572 | LOMA LINDA UNIVERSITY MEDICAL CENTER (LLUMC) CRANIAL REMOLDING HELMET | Rehabilitation Institute,Loma Linda University Med | 2003-01-13 | Traditional | PDF ↗ |
| K022273 | CRANIAL SYMMETRY SYSTEM | Beverly Hills Prosthetics Orthotics, Inc. | 2002-09-09 | Traditional | PDF ↗ |
| K021221 | O&P CRANICAL MOLDING HELMET | Orthotic & Prosthetic Lab, Inc. | 2002-07-01 | Traditional | PDF ↗ |
| K020448 | STATIC CRANIOPLASTY ORTHOSIS | Eastern Cranial Affiliates | 2002-04-12 | Traditional | PDF ↗ |
| K013700 | ORTHOSIS HELMET MOLDING | Precision Prosthetics & Orthotics, Inc. | 2002-02-05 | Traditional | PDF ↗ |
| K013719 | BECKER BAND CRANIAL REMOLDING ORTHOSIS | Becker Orthopedic Appliance Co. | 2002-02-05 | Traditional | PDF ↗ |
| K012804 | PLAGIOCEPHALIC APPLIED PRESSURE ORTHOSIS P.A.P. ORTHOSIS | Scott E Allen CP | 2002-01-17 | Traditional | PDF ↗ |
| K012920 | MOLDED CRANIAL HELMET | Fairview Orthopedic Laboratory | 2001-11-28 | Traditional | PDF ↗ |
| K012830 | LERMAN & SON CRANIAL ORTHOSIS HELMET | Lerman & Son | 2001-11-20 | Traditional | PDF ↗ |
| K013458 | CRANIAL HELMET | Children'S Hospital | 2001-10-29 | Traditional | PDF ↗ |
| K012007 | RHS HELMET | Restorative Health Svs, Inc. | 2001-09-19 | Traditional | PDF ↗ |
| K011433 | BALLERT CRANIAL MOLDING HELMET | Gema, Inc. | 2001-06-12 | Traditional | PDF ↗ |
| K003035 | CLARREN HELMET | Children'S Hospital & Medical Center | 2001-06-06 | Traditional | PDF ↗ |
| K003630 | DANMAR PRODUCTS MICHIGAN CRANIAL HELMET | Danmar Products, Inc. | 2001-05-29 | Traditional | PDF ↗ |
| K010273 | CRANIAL MOLDING ORTHOSIS | Orthotic Solutions, Inc. | 2001-04-25 | Traditional | PDF ↗ |
| K001669 | HANGER CRANIAL BAND | Hanger Orthopedic Group, Inc. | 2000-12-08 | Traditional | PDF ↗ |
| K000861 | CRANIOCAP | Gillette Children'S Specialty Healthcare | 2000-10-30 | Traditional | PDF ↗ |
| K001167 | OPI BAND | Orthomerica Products, Inc. | 2000-07-07 | Traditional | PDF ↗ |
| DEN980001 | DYNAMIC ORTHOTIC CRANIOPLASTY BAND; DOC BAND | Cranial Technologies, Inc. | 1998-05-29 | Post-NSE | — |
Product code MVA · Class II · Neurology. Data: openFDA.