FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Galileo Vertebral Body Replacement Device
K Number: K192145
·
Decision Apr 21, 2020
Classifications
1
FEI Numbers
69
Registration Numbers
69
Same Product Code
17
Applicant Total
2
Review Days
257
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Basic Information
- Device Name
- Galileo Vertebral Body Replacement Device
- K Number
- K192145
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3060
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Bright Spine
- Date Received
- August 8, 2019
- Decision Date
- April 21, 2020
- Product Code
- PLR
- 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 |
|---|---|---|---|
| PLR | Spinal Vertebral Body Replacement Device - Cervical | FDA class 2 | Orthopedic |
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Other Clearances by Bright Spine
| K Number | Device Name | ||
|---|---|---|---|
| K221542 | Galileo Vertebral Body Replacement Device | Jan 13, 2023 | Substantially Equivalent |