FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Sternal Cable System
K Number: K180582
·
Decision May 31, 2018
Classifications
1
FEI Numbers
155
Registration Numbers
155
Same Product Code
128
Applicant Total
4
Review Days
87
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Basic Information
- Device Name
- Sternal Cable System
- K Number
- K180582
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3010
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- A & E Medical Corporation
- Date Received
- March 5, 2018
- Decision Date
- May 31, 2018
- 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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