IlluminOss Bone Stabilization System
FDA 510(k) clearance K181228 · decided 2018-08-31
Clearance details
- K-number
- K181228
- Device name
- IlluminOss Bone Stabilization System
- Applicant
- Illuminoss Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2018-05-08
- Decision date
- 2018-08-31
- Days to decision
- 115 days
- Clearance type
- Traditional
- Product code
- QAD
- Device class
- 2
- Regulation number
- 888.3023
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- East Providence, RI, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| IlluminOss Photodynamic Bone Stabilization System (K233436) | Illuminoss Medical, Inc. | 2024-01-19 |
| IlluminOss Bone Stabilization System (K202887) | Illuminoss Medical, Inc. | 2020-10-27 |
| IlluminOss Photodynamic Bone Stabilization System (K201961) | Illuminoss Medical, Inc. | 2020-08-13 |
| IlluminOss Bone Stabilization System (K200295) | Illuminoss Medical, Inc. | 2020-06-25 |
| IlluminOss Photodynamic Bone Stabilization System (K183145) | Illuminoss Medical, Inc. | 2018-12-13 |
| IlluminOss Bone Stabilization System (DEN160062) | Illminoss Medical, Inc. | 2017-12-19 |
Recalls involving this device
No recalls on record reference this clearance.