FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇳 India
4CIS BLACK MARLIN PLIF CAGE SYSTEM, 4CIS DOLPHIN TLIF CAGE SYSTEM
K Number: K213653
·
Decision Dec 19, 2022
Classifications
1
FEI Numbers
418
Registration Numbers
418
Same Product Code
890
Applicant Total
2
Review Days
395
Basic Information
- Device Name
- 4CIS BLACK MARLIN PLIF CAGE SYSTEM, 4CIS DOLPHIN TLIF CAGE SYSTEM
- K Number
- K213653
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3080
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Solco Biomedical Company India Private Limited
- Date Received
- November 19, 2021
- Decision Date
- December 19, 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 Solco Biomedical Company India Private Limited
| K Number | Device Name | ||
|---|---|---|---|
| K202498 | 4CIS SARA Spine System, 4CIS VERTU Spine System | Feb 18, 2021 | Substantially Equivalent |