FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
DSS STABILIZATION SYSTEM-RIGID
K Number: K120491
·
Decision May 9, 2012
Classifications
1
FEI Numbers
326
Registration Numbers
326
Same Product Code
308
Applicant Total
11
Review Days
82
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Basic Information
- Device Name
- DSS STABILIZATION SYSTEM-RIGID
- K Number
- K120491
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3070
- Medical Specialty
- Orthopedic
- Decision
- Unknown
- Statement or Summary
- Summary
- Applicant
- Paradigm Spine, LLC
- Date Received
- February 17, 2012
- Decision Date
- May 9, 2012
- Product Code
- MNH
- 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 |
|---|---|---|---|
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | FDA class 2 | Orthopedic |
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Other Clearances by Paradigm Spine, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K153302 | coflex-IF | Sep 8, 2016 | Substantially Equivalent |
| K112595 | COFLEX-F | Feb 13, 2012 | Substantially Equivalent |
| K113625 | DSS STABILIZATION SYSTEM | Jan 10, 2012 | Unknown |
| K093438 | PARADIGM INTERSPINOUS FUSION PLATE | Oct 6, 2010 | Substantially Equivalent |
| K101083 | DSS STABILIZATION SYSTEM | Jul 2, 2010 | Unknown |
| K091944 | MODIFICATION TO: DSS STABILIZATION SYSTEM | Aug 3, 2009 | Substantially Equivalent |
| K090099 | DSS STABILIZATION SYSTEM | Jun 19, 2009 | Unknown |
| K090408 | MODIFICATION TO: DSS STABILIZATION SYSTEM | Mar 20, 2009 | Unknown |
| K080241 | DDS STABILIZATION SYSTEM | Nov 28, 2008 | Unknown |
| K072969 | DSS | Jan 24, 2008 | Unknown |