FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
STARband 3D
K Number: K223238
·
Decision Apr 20, 2023
Classifications
1
FEI Numbers
16
Registration Numbers
16
Same Product Code
42
Applicant Total
21
Review Days
182
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Basic Information
- Device Name
- STARband 3D
- K Number
- K223238
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5970
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Orthomerica Products, Inc.
- Date Received
- October 20, 2022
- Decision Date
- April 20, 2023
- Product Code
- MVA
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MVA | Orthosis, Cranial | FDA class 2 | Neurology |
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Other Clearances by Orthomerica Products, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K240466 | STARband 3D | Mar 15, 2024 | Substantially Equivalent |
| K211376 | STARband | Aug 17, 2021 | Substantially Equivalent |
| K203098 | STARband, STARlight, St. Louis Band | Apr 27, 2021 | Substantially Equivalent |
| K180109 | STARband, STARlight, St. Louis Band | Mar 1, 2018 | Substantially Equivalent |
| K161138 | St. Louis Band | Jul 20, 2016 | Substantially Equivalent |
| K151979 | STARband, STARlight | Sep 18, 2015 | Substantially Equivalent |
| K151147 | STARband, STARlight | Jul 1, 2015 | Substantially Equivalent |
| K142141 | STARBAND, STARLIGHT | Apr 23, 2015 | Substantially Equivalent |
| K141842 | STARBAND, STARLIGHT | Oct 6, 2014 | Substantially Equivalent |
| K140353 | STARBAND AND STARLIGHT | Jun 6, 2014 | Substantially Equivalent |