FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Thorecon Fixation System
K Number: K173579
·
Decision Feb 12, 2018
Classifications
1
FEI Numbers
155
Registration Numbers
155
Same Product Code
128
Applicant Total
4
Review Days
84
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Basic Information
- Device Name
- Thorecon Fixation System
- K Number
- K173579
- 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
- November 20, 2017
- Decision Date
- February 12, 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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