STARband 3D
FDA 510(k) clearance K223238 · decided 2023-04-20
Clearance details
- K-number
- K223238
- Device name
- STARband 3D
- Applicant
- Orthomerica Products, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2022-10-20
- Decision date
- 2023-04-20
- Days to decision
- 182 days
- Clearance type
- Traditional
- Product code
- MVA
- Device class
- 2
- Regulation number
- 882.5970
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Orlando, FL, US
- Third-party review
- No
- Expedited review
- No
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| Record | Firm | Date |
|---|---|---|
| Talee, Talee PostOp (K241957) | Invent Medical USA, LLC | 2024-08-30 |
| Talee, Talee PostOp (K230444) | Invent Medical USA, LLC | 2023-06-22 |
| Talee, Talee PostOP (K220681) | Invent Medical USA, LLC | 2022-09-22 |
| Hanger Cranial Band 3D (K203134) | Symbion Logistics, LLC | 2022-07-01 |
| MyCRO Band (K213587) | Otto Bock Healthcare LP | 2022-06-09 |
| SnugKap (K193383) | Headstart, Ltd. | 2021-06-07 |
| MyCRO Band (K201426) | Otto Bock Healthcare LP | 2021-03-26 |
| KidCap (K180568) | Eastern Cranial Affiliates, LLC | 2018-10-16 |
| STARBAND, STARLIGHT (K141842) | Orthomerica Products, Inc. | 2014-10-06 |
| STARBAND AND STARLIGHT (K140353) | Orthomerica Products, Inc. | 2014-06-06 |
| P-POD (K133397) | P-Pod | 2014-04-18 |
| BOSTON BAND (K111609) | Boston Brace Intl., Inc. | 2011-08-22 |
Recalls involving this device
No recalls on record reference this clearance.