FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Valeo II Interbody Fusion Device System
K Number: K161405
·
Decision Aug 19, 2016
Classifications
1
FEI Numbers
418
Registration Numbers
418
Same Product Code
890
Applicant Total
16
Review Days
91
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Basic Information
- Device Name
- Valeo II Interbody Fusion Device System
- K Number
- K161405
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 888.3080
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Amedica Corp.
- Date Received
- May 20, 2016
- Decision Date
- August 19, 2016
- Product Code
- MAX
- 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 |
|---|---|---|---|
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | FDA class 2 | Orthopedic |
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FDA 510(k)
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Other Clearances by Amedica Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K173453 | Valeo® C+CSC with Lumen Interbody Fusion Device | Mar 5, 2018 | Substantially Equivalent |
| K143518 | Valeo Spacer System and Valeo II Interbody Fusion Device System | Oct 2, 2015 | Substantially Equivalent |
| K142264 | Valeo C Spacer System, Valeo II C IBF Device | Dec 8, 2014 | Substantially Equivalent |
| K142347 | Amedica Valeo II Interbody Fusion Device | Nov 18, 2014 | Substantially Equivalent |
| K121892 | PHANTOM PLUS CERAMIC CAGE SYSTEM | Aug 24, 2012 | Substantially Equivalent |
| K091278 | VALEO SPACER SYSTEM | Jan 28, 2010 | Substantially Equivalent |
| K082037 | SEEPLATE CERVICAL PLATE SYSTEM | Sep 26, 2008 | Substantially Equivalent |
| K073430 | VALEO PEDICLE SCREW SPINAL SYSTEM | Jan 29, 2008 | Substantially Equivalent |
| K073505 | MODIFICATION TO VALEO VBR | Jan 9, 2008 | Substantially Equivalent |
| K073125 | VALEO VBR | Dec 5, 2007 | Substantially Equivalent |