FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CorticaLINK Spinal Fusion Platform
K Number: K160722
·
Decision Jul 7, 2016
Classifications
1
FEI Numbers
407
Registration Numbers
407
Same Product Code
900
Applicant Total
2
Review Days
113
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Basic Information
- Device Name
- CorticaLINK Spinal Fusion Platform
- K Number
- K160722
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3070
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Facetlink Dba Linkspine
- Date Received
- March 16, 2016
- Decision Date
- July 7, 2016
- Product Code
- NKB
- 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 |
|---|---|---|---|
| NKB | Thoracolumbosacral Pedicle Screw System | FDA class 2 | Orthopedic |
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Other Clearances by Facetlink Dba Linkspine
| K Number | Device Name | ||
|---|---|---|---|
| K162693 | VertebraLINK Fusion Platform | Mar 29, 2017 | Substantially Equivalent |