FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FRONTIER SADL INTERBODY FUSION DEVICE
K Number: K112700
·
Decision Nov 1, 2012
Classifications
1
FEI Numbers
253
Registration Numbers
253
Same Product Code
200
Applicant Total
5
Review Days
412
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Basic Information
- Device Name
- FRONTIER SADL INTERBODY FUSION DEVICE
- K Number
- K112700
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3080
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Frontier Medical Devices, Inc.
- Date Received
- September 16, 2011
- Decision Date
- November 1, 2012
- Product Code
- OVD
- 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 |
|---|---|---|---|
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | 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 |
| K151346 | Frontier Medical Devices Posterior Cable Screw System | Aug 20, 2015 | Substantially Equivalent |
| K143228 | Ancora LLC Interbody Fusion Device | Feb 26, 2015 | Substantially Equivalent |