FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
Velofix SA Cervical Cage
K Number: K210573
·
Decision Nov 19, 2021
Classifications
1
FEI Numbers
230
Registration Numbers
230
Same Product Code
161
Applicant Total
23
Review Days
266
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Basic Information
- Device Name
- Velofix SA Cervical Cage
- K Number
- K210573
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3080
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- U&I Corporation
- Date Received
- February 26, 2021
- Decision Date
- November 19, 2021
- Product Code
- OVE
- 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 |
|---|---|---|---|
| OVE | Intervertebral Fusion Device With Integrated Fixation, Cervical | FDA class 2 | Orthopedic |
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Other Clearances by U&I Corporation
| K Number | Device Name | ||
|---|---|---|---|
| K220147 | Aspiron S ACP System | Feb 16, 2022 | Substantially Equivalent |
| K183243 | Velofix TLIF Cage | Jul 10, 2019 | Substantially Equivalent |
| K190067 | Velofix Interbody Fusion System | Feb 4, 2019 | Substantially Equivalent |
| K190053 | SECULOK ACP System | Feb 1, 2019 | Substantially Equivalent |
| K181824 | CBT Screw Fixation System | Dec 13, 2018 | Substantially Equivalent |
| K183383 | ANAX OCT Spinal System | Dec 12, 2018 | Substantially Equivalent |
| K181829 | Velofix TLIF Cage | Nov 14, 2018 | Substantially Equivalent |
| K182055 | SECULOK ACP System | Sep 10, 2018 | Substantially Equivalent |
| K180759 | SECULOK Suture Anchor | Aug 9, 2018 | Substantially Equivalent |
| K173198 | Facet Screw Fixation System | Jan 3, 2018 | Substantially Equivalent |