FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
IRENE Thoracolumbar Fixation System
K Number: K172267
·
Decision Mar 6, 2018
Classifications
1
FEI Numbers
407
Registration Numbers
407
Same Product Code
900
Applicant Total
3
Review Days
222
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Basic Information
- Device Name
- IRENE Thoracolumbar Fixation System
- K Number
- K172267
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3070
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Tianjin Zhengtian Medical Instrument Co., Ltd.
- Date Received
- July 27, 2017
- Decision Date
- March 6, 2018
- Product Code
- NKB
- 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 |
|---|---|---|---|
| NKB | Thoracolumbosacral Pedicle Screw System | FDA class 2 | Orthopedic |
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