FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
Bfix Orthopedic External Fixator Systems
K Number: K200491
·
Decision Jan 5, 2021
Classifications
1
FEI Numbers
249
Registration Numbers
249
Same Product Code
403
Applicant Total
1
Review Days
312
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Basic Information
- Device Name
- Bfix Orthopedic External Fixator Systems
- K Number
- K200491
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3030
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Aike (Shanghai) Medical Instrument Co., Ltd.
- Date Received
- February 28, 2020
- Decision Date
- January 5, 2021
- Product Code
- KTT
- 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 |
|---|---|---|---|
| KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | FDA class 2 | Orthopedic |
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