FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Anteralign Spinal System with Titan nanoLOCK Surface Technology
K Number: K214010
·
Decision Apr 12, 2022
Classifications
1
FEI Numbers
418
Registration Numbers
418
Same Product Code
890
Applicant Total
9
Review Days
111
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Basic Information
- Device Name
- Anteralign Spinal System with Titan nanoLOCK Surface Technology
- K Number
- K214010
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3080
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medtronic Sofamor Danek USA
- Date Received
- December 22, 2021
- Decision Date
- April 12, 2022
- Product Code
- MAX
- 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 |
|---|---|---|---|
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | FDA class 2 | Orthopedic |
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Other Clearances by Medtronic Sofamor Danek USA
| K Number | Device Name | ||
|---|---|---|---|
| K170347 | CD HORIZON Fenestrated Screw Set | Apr 4, 2017 | Substantially Equivalent |
| K133904 | CD HORIZON SPINAL SYSTEM GROWTH ROD SET | Feb 25, 2014 | Substantially Equivalent |
| K132111 | CD HORIZON SPINAL SYSTEM | Aug 6, 2013 | Substantially Equivalent |
| K131321 | CD HORIZON SPINAL SYSTEM | Jun 5, 2013 | Substantially Equivalent |
| K123978 | CAPSTONE L SPINAL SYSTEM | Apr 9, 2013 | Substantially Equivalent |
| K113642 | PERIMETER INTERBODY FUSION DEVICE | Feb 6, 2012 | Substantially Equivalent |
| K110562 | TELAMON PEEK SPINAL SYSTEM | Nov 9, 2011 | Substantially Equivalent |
| K111264 | CORNERSTONE (R) PSR CERVICAL FUSION SYSTEM | Oct 12, 2011 | Substantially Equivalent |