FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
LumFix Spinal Fixation Sytem
K Number: K160731
·
Decision Oct 4, 2016
Classifications
1
FEI Numbers
342
Registration Numbers
342
Same Product Code
302
Applicant Total
5
Review Days
201
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Basic Information
- Device Name
- LumFix Spinal Fixation Sytem
- K Number
- K160731
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3070
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- CG Bio Co., Ltd.
- Date Received
- March 17, 2016
- Decision Date
- October 4, 2016
- Product Code
- MNI
- 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 |
|---|---|---|---|
| MNI | Orthosis, Spinal Pedicle Fixation | FDA class 2 | Orthopedic |
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Other Clearances by CG Bio Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K252251 | EASYMADE-TI | Apr 9, 2026 | Substantially Equivalent |
| K250582 | COLONNADE Posterior Screw Fixation System | May 8, 2025 | Substantially Equivalent |
| K222229 | Advanced LumFix Spinal Fixation System | May 25, 2023 | Substantially Equivalent |
| K122490 | KULAVAC | Nov 13, 2013 | Substantially Equivalent |