MVA — Orthosis, Cranial Class II
FDA product code MVA covers "Orthosis, Cranial", a Class II medical device regulated under 21 CFR 882.5970. Submissions are reviewed by the Neurology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- MVA
- Device Class
- Class II
- Regulation Number
- 882.5970
- Submission Type
- Review Panel
- NE
- Medical Specialty
- Neurology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K241957 | invent medical usa | Talee, Talee PostOp | August 30, 2024 |
| K230444 | invent medical usa | Talee, Talee PostOp | June 22, 2023 |
| K223238 | orthomerica products | STARband 3D | April 20, 2023 |
| K220681 | invent medical usa | Talee, Talee PostOP | September 22, 2022 |
| K203134 | symbion logistics | Hanger Cranial Band 3D | July 1, 2022 |
| K213587 | otto bock healthcare | MyCRO Band | June 9, 2022 |
| K193383 | headstart | SnugKap | June 7, 2021 |
| K201426 | otto bock healthcare | MyCRO Band | March 26, 2021 |
| K180568 | eastern cranial affiliates | KidCap | October 16, 2018 |
| K141842 | orthomerica products | STARBAND, STARLIGHT | October 6, 2014 |
| K140353 | orthomerica products | STARBAND AND STARLIGHT | June 6, 2014 |
| K133397 | p-pod | P-POD | April 18, 2014 |
| K111609 | boston brace intl | BOSTON BAND | August 22, 2011 |
| K111247 | orthotic care services | CRANIAL REMOLDING ORTHOSIS | August 15, 2011 |
| K103362 | advanced orthopro | AOI CRANIAL HELMET | April 18, 2011 |
| K090341 | danmar products | MICHIGAN CRANIAL RESHAPING ORTHOSIS | January 6, 2010 |
| K070694 | mike miner | CCRO (CRANIOCEPHALIC CUSTOM REMOLDING ORTHOSIS) | September 10, 2007 |
| K063133 | cranial solutions | CRANIAL SOLUTION ORTHOSIS | July 2, 2007 |
| K063395 | orthotic and prosthetic lab | O&P BIVALVE CRANIAL MOLDING HELMET | December 22, 2006 |
| K042385 | cranial technologies | DOC BAND-POSTOP | December 17, 2004 |