FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Smith & Nephew ACCORD Cable System
K Number: K223762
·
Decision May 30, 2023
Classifications
1
FEI Numbers
519
Registration Numbers
519
Same Product Code
1313
Applicant Total
16
Review Days
166
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Basic Information
- Device Name
- Smith & Nephew ACCORD Cable System
- K Number
- K223762
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3030
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Smith & Nephew
- Date Received
- December 15, 2022
- Decision Date
- May 30, 2023
- Product Code
- HRS
- 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 |
|---|---|---|---|
| HRS | Plate, Fixation, Bone | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
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