510(k) K063098
- Device
- STATIC CRANIOPLASTY ORTHOSIS
- Applicant
- BOSTON BRACE INTL., INC.
- 510(k) number
- K063098
- Product code
- OAN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2007-04-11
- Date received
- 2006-10-10
- Regulation
- 882.5970
- Classification name
- Orthosis, Cranial, Laser Scan
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- JAMES WYNNE
- Address
- 20 Ledin Dr. Avon MA US 02322 02322
FDA Registration Numbers#
- 2032381
- 2030829
- 3015259854
- 3042028951
- 3003895329
- 1215709
- 1000246715
- 1000560772
- 1058152
- 1000239400
- 1831680
- 3038871395
- 1721652
Source Documents#
Other 510(k) Records For Product Code OAN #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K244056 | DOC Band 3D | Cranial Technologies, Inc. | 2025-03-17 |
| K240466 | STARband 3D | Orthomerica Products, Inc. | 2024-03-15 |
| K211376 | STARband | Orthomerica Products, Inc. | 2021-08-17 |
| K203098 | STARband, STARlight, St. Louis Band | Orthomerica Products, Inc. | 2021-04-27 |
| K180109 | STARband, STARlight, St. Louis Band | Orthomerica Products, Inc. | 2018-03-01 |
| K161138 | St. Louis Band | Orthomerica Products, Inc. | 2016-07-20 |
| K151979 | STARband, STARlight | Orthomerica Products, Inc. | 2015-09-18 |
| K151147 | STARband, STARlight | Orthomerica Products, Inc. | 2015-07-01 |
| K142141 | STARBAND, STARLIGHT | Orthomerica Products, Inc. | 2015-04-23 |
| K133250 | STARLIGHT | Orthomerica Products, Inc. | 2014-01-16 |
| K124023 | STARBAND | Orthomerica Products, Inc. | 2013-06-10 |
| K090587 | STARLIGHT | Orthomerica Products, Inc. | 2009-07-17 |
| K081787 | CAMLAB CRANIAL ORTHOSIS HELMET | Biosculptor Corporation | 2009-01-27 |
| K082950 | STARBAND | Orthomerica Products, Inc. | 2008-12-05 |
| K082945 | STARLIGHT | Orthomerica Products, Inc. | 2008-10-31 |
Legacy Summary#
summary
FDA Review#
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