FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
Shanghai Sanyou CARMEN Cervical Fusion System
K Number: K163366
·
Decision Oct 5, 2017
Classifications
1
FEI Numbers
356
Registration Numbers
356
Same Product Code
665
Applicant Total
9
Review Days
309
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Basic Information
- Device Name
- Shanghai Sanyou CARMEN Cervical Fusion System
- K Number
- K163366
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3060
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Shanghai Sanyou Medical Co, Ltd.
- Date Received
- November 30, 2016
- Decision Date
- October 5, 2017
- 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 Shanghai Sanyou Medical Co, Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K230872 | Halis Lumbar Cage System, Lydia Anterior Lumbar Fusion System, Dica Direction Changeable Lumbar Cage System, KEYSTONE Cage System | Dec 12, 2023 | Substantially Equivalent |
| K230961 | Zeus Spinal System | Oct 10, 2023 | Substantially Equivalent |
| K231931 | Adena-Zina Spinal System | Jul 28, 2023 | Substantially Equivalent |
| K211689 | KEYSTONE PEEK Cage System | Sep 21, 2021 | Substantially Equivalent |
| K212066 | Adena-Zina System | Aug 16, 2021 | Substantially Equivalent |
| K163422 | Shanghai Sanyou PEEK Cage System | Sep 18, 2017 | Substantially Equivalent |
| K152781 | Adena-Zina System | Feb 12, 2016 | Substantially Equivalent |
| K131512 | KATIA SYSTEM | Aug 7, 2013 | Substantially Equivalent |