FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
Velofix(tm) Interbody Fusion System
K Number: K171749
·
Decision Jul 13, 2017
Classifications
1
FEI Numbers
339
Registration Numbers
339
Same Product Code
348
Applicant Total
23
Review Days
30
Basic Information
- Device Name
- Velofix(tm) Interbody Fusion System
- K Number
- K171749
- 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
- June 13, 2017
- Decision Date
- July 13, 2017
- Product Code
- ODP
- 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 |
|---|---|---|---|
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (ODP), ordered by most recent decision date.
BluEX Cervical Expandable Cage System
FDA 510(k)
FDA Class 2
·Orthopedic
OSTEOMNI SPINAL CAGES SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
ZSFab Cervical Interbody System and ZSFab Lumbar Interbody System
FDA 510(k)
FDA Class 2
·Orthopedic
ORIO-3D Cage System
FDA 510(k)
FDA Class 2
·Orthopedic
HC BIOLOGICS OSTEOPOINT PEEK CAGES, HC BIOLOGICS OSTEOPOINT CERVICAL PEEK CAGES, HC BIOLOGICS OSTEOPOINT LUMBAR PEEK CAGES
FDA 510(k)
FDA Class 2
·Orthopedic
MOD-C
FDA 510(k)
FDA Class 2
·Orthopedic
Other Clearances by U&I Corporation
| K Number | Device Name | ||
|---|---|---|---|
| K220147 | Aspiron S ACP System | Feb 16, 2022 | Substantially Equivalent |
| K210573 | Velofix SA Cervical Cage | Nov 19, 2021 | 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 |