510(k) K181228
- Device
- IlluminOss Bone Stabilization System
- Applicant
- IlluminOss Medical, Inc.
- 510(k) number
- K181228
- Product code
- QAD
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2018-08-31
- Date received
- 2018-05-08
- Regulation
- 888.3023
- Classification name
- Rod, Fixation, Intramedullary And Accessories, In-vivo Cured, Light-activated
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Robert Rabiner
- Address
- 993 Waterman Ave. East Providence RI US 02914 02914
FDA Registration Numbers#
- 3006845464
- 1222747
Source Documents#
Other 510(k) Records For Product Code QAD #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K233436 | IlluminOss Photodynamic Bone Stabilization System | Illuminoss Medical, Inc. | 2024-01-19 |
| K202887 | IlluminOss Bone Stabilization System | Illuminoss Medical, Inc. | 2020-10-27 |
| K201961 | IlluminOss Photodynamic Bone Stabilization System | Illuminoss Medical, Inc. | 2020-08-13 |
| K200295 | IlluminOss Bone Stabilization System | Illuminoss Medical, Inc. | 2020-06-25 |
| K183145 | IlluminOss Photodynamic Bone Stabilization System | Illuminoss Medical, Inc. | 2018-12-13 |
| DEN160062 | IlluminOss Bone Stabilization System | Illminoss Medical, Inc. | 2017-12-19 |
Legacy Summary#
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FDA Review#
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