FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
Metal Cannulated Screw
K Number: K221090
·
Decision Jan 10, 2023
Classifications
1
FEI Numbers
659
Registration Numbers
659
Same Product Code
1058
Applicant Total
12
Review Days
272
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Basic Information
- Device Name
- Metal Cannulated Screw
- K Number
- K221090
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3040
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Double Medical Technology, Inc.
- Date Received
- April 13, 2022
- Decision Date
- January 10, 2023
- Product Code
- HWC
- 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 |
|---|---|---|---|
| HWC | Screw, Fixation, Bone | FDA class 2 | Orthopedic |
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| K221150 | Advanced Bone Plate | Jan 25, 2023 | Substantially Equivalent |
| K221088 | Anatomic Bone Plate | Jan 18, 2023 | Substantially Equivalent |
| K221221 | Advanced Intramedullary Nail System | Dec 21, 2022 | Substantially Equivalent |
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| K172830 | Double Medical Femoral Nail System | Aug 24, 2018 | Substantially Equivalent |
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