FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ACCORD Cable System
K Number: K233949
·
Decision Mar 13, 2024
Classifications
1
FEI Numbers
155
Registration Numbers
155
Same Product Code
128
Applicant Total
529
Review Days
90
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Basic Information
- Device Name
- ACCORD Cable System
- K Number
- K233949
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3010
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Smith & Nephew, Inc.
- Date Received
- December 14, 2023
- Decision Date
- March 13, 2024
- Product Code
- JDQ
- 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 |
|---|---|---|---|
| JDQ | Cerclage, Fixation | FDA class 2 | Orthopedic |
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