FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
INFILL CERVICAL
K Number: K140066
·
Decision May 5, 2014
Classifications
1
FEI Numbers
339
Registration Numbers
339
Same Product Code
348
Applicant Total
12
Review Days
115
Basic Information
- Device Name
- INFILL CERVICAL
- K Number
- K140066
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3080
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Pinnacle Spine Group, LLC
- Date Received
- January 10, 2014
- Decision Date
- May 5, 2014
- Product Code
- ODP
- 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 |
|---|---|---|---|
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | FDA class 2 | Orthopedic |
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Other Clearances by Pinnacle Spine Group, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K172349 | InFill® Interbody Fusion Device | Dec 14, 2017 | Substantially Equivalent |
| K152259 | InFill Interbody Fusion Device | Nov 19, 2015 | Substantially Equivalent |
| K151184 | InFill Interbody Fusion Devices | Jul 14, 2015 | Substantially Equivalent |
| K150206 | InFill Interbody Fusion Devices | Apr 3, 2015 | Substantially Equivalent |
| K143488 | InFill Graft Delivery System | Dec 17, 2014 | Substantially Equivalent |
| K133721 | INFILL 41-TLIF CONVEX OBLIQUE DEVICE, INFILL 43-TLIF CONTOUR OBLIQUE, INFILL 44-TLIF CONTOUR OBLIQUE AND THE INFILL 60 | Mar 31, 2014 | Substantially Equivalent |
| K124012 | INFILL OBLIQUE TLIF DEVICE | Jun 4, 2013 | Substantially Equivalent |
| K121476 | INFILL GRAFT DELIVERY SYSTEM | Aug 29, 2012 | Substantially Equivalent |
| K121733 | INFILL INTERVERTEBRAL BODY FUSION DEVICE | Jul 13, 2012 | Substantially Equivalent |
| K111632 | INFILL GRAFT DELIVERY SYSTEM | Aug 11, 2011 | Substantially Equivalent |