FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Frontier Medical Devices Posterior Cable Screw System
K Number: K151346
·
Decision Aug 20, 2015
Classifications
1
FEI Numbers
155
Registration Numbers
155
Same Product Code
128
Applicant Total
5
Review Days
92
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Basic Information
- Device Name
- Frontier Medical Devices Posterior Cable Screw System
- K Number
- K151346
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3010
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Frontier Medical Devices, Inc.
- Date Received
- May 20, 2015
- Decision Date
- August 20, 2015
- 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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Other Clearances by Frontier Medical Devices, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K153242 | Frontier Medical Devices In-Line Orthopedic Cable Cerclage System | Jan 13, 2016 | Substantially Equivalent |
| K151888 | Frontier Medical Devices In-line Orthopedic Cable Cerclage System | Oct 30, 2015 | Substantially Equivalent |
| K143228 | Ancora LLC Interbody Fusion Device | Feb 26, 2015 | Substantially Equivalent |
| K112700 | FRONTIER SADL INTERBODY FUSION DEVICE | Nov 1, 2012 | Substantially Equivalent |