FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
SECULOK ACP System
K Number: K182055
·
Decision Sep 10, 2018
Classifications
1
FEI Numbers
356
Registration Numbers
356
Same Product Code
665
Applicant Total
23
Review Days
41
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Basic Information
- Device Name
- SECULOK ACP System
- K Number
- K182055
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3060
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- U&I Corporation
- Date Received
- July 31, 2018
- Decision Date
- September 10, 2018
- Product Code
- KWQ
- 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 |
|---|---|---|---|
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 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 |
| 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 |
| K180759 | SECULOK Suture Anchor | Aug 9, 2018 | Substantially Equivalent |
| K173198 | Facet Screw Fixation System | Jan 3, 2018 | Substantially Equivalent |