FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
IlluminOss Bone Stabilization System
K Number: K181228
·
Decision Aug 31, 2018
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
6
Applicant Total
6
Review Days
115
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Basic Information
- Device Name
- IlluminOss Bone Stabilization System
- K Number
- K181228
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3023
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Illuminoss Medical, Inc.
- Date Received
- May 8, 2018
- Decision Date
- August 31, 2018
- Product Code
- QAD
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- OR
- 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 |
|---|---|---|---|
| QAD | Rod, Fixation, Intramedullary And Accessories, In-Vivo Cured, Light-Activated | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (QAD), ordered by most recent decision date.
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Other Clearances by Illuminoss Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K233436 | IlluminOss Photodynamic Bone Stabilization System | Jan 19, 2024 | Substantially Equivalent |
| K202887 | IlluminOss Bone Stabilization System | Oct 27, 2020 | Substantially Equivalent |
| K201961 | IlluminOss Photodynamic Bone Stabilization System | Aug 13, 2020 | Substantially Equivalent |
| K200295 | IlluminOss Bone Stabilization System | Jun 25, 2020 | Substantially Equivalent |
| K183145 | IlluminOss Photodynamic Bone Stabilization System | Dec 13, 2018 | Substantially Equivalent |