FDA Product Code
FDA Product Code OAN — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Neurology
- 21 CFR Citation
- 882.5970
510(k) Clearances — 23 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K244056 | DOC Band 3D | Cranial Technologies, Inc. | 2025-03-17 | Traditional | PDF ↗ |
| K240466 | STARband 3D | Orthomerica Products, Inc. | 2024-03-15 | Special | PDF ↗ |
| K211376 | STARband | Orthomerica Products, Inc. | 2021-08-17 | Special | PDF ↗ |
| K203098 | STARband, STARlight, St. Louis Band | Orthomerica Products, Inc. | 2021-04-27 | Traditional | PDF ↗ |
| K180109 | STARband, STARlight, St. Louis Band | Orthomerica Products, Inc. | 2018-03-01 | Special | PDF ↗ |
| K161138 | St. Louis Band | Orthomerica Products, Inc. | 2016-07-20 | Traditional | PDF ↗ |
| K151979 | STARband, STARlight | Orthomerica Products, Inc. | 2015-09-18 | Traditional | PDF ↗ |
| K151147 | STARband, STARlight | Orthomerica Products, Inc. | 2015-07-01 | Traditional | PDF ↗ |
| K142141 | STARBAND, STARLIGHT | Orthomerica Products, Inc. | 2015-04-23 | Traditional | PDF ↗ |
| K133250 | STARLIGHT | Orthomerica Products, Inc. | 2014-01-16 | Traditional | PDF ↗ |
| K124023 | STARBAND | Orthomerica Products, Inc. | 2013-06-10 | Traditional | PDF ↗ |
| K090587 | STARLIGHT | Orthomerica Products, Inc. | 2009-07-17 | Special | PDF ↗ |
| K081787 | CAMLAB CRANIAL ORTHOSIS HELMET | Biosculptor Corporation | 2009-01-27 | Traditional | PDF ↗ |
| K082950 | STARBAND | Orthomerica Products, Inc. | 2008-12-05 | Traditional | PDF ↗ |
| K082945 | STARLIGHT | Orthomerica Products, Inc. | 2008-10-31 | Special | PDF ↗ |
| K081994 | STARLIGHT | Orthomerica Products, Inc. | 2008-09-12 | Traditional | PDF ↗ |
| K072862 | BOSTON-BAND CRANIAL REMODLING ORTHOSIS | Boston Brace Intl., Inc. | 2008-01-22 | Special | PDF ↗ |
| K072566 | HANGER CRANIAL BAND | Hanger Prosthetics & Orthotics, Inc. | 2008-01-09 | Traditional | PDF ↗ |
| K063098 | STATIC CRANIOPLASTY ORTHOSIS | Boston Brace Intl., Inc. | 2007-04-11 | Traditional | PDF ↗ |
| K021918 | CLARREN HELMET (ORTHOMERICA) | Orthomerica Products, Inc. | 2002-07-25 | Traditional | PDF ↗ |
| K021207 | STARLIGHT | Orthomerica Products, Inc. | 2002-07-09 | Traditional | PDF ↗ |
| K014012 | DOC BAND | Cranial Technologies, Inc. | 2002-01-28 | Traditional | PDF ↗ |
| K011350 | STARBAND CRANIAL ORTHOSIS | Orthomerica Products, Inc. | 2001-07-03 | Traditional | PDF ↗ |
Product code OAN · Class II · Neurology. Data: openFDA.