FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
DSS STABILIZATION SYSTEM
K Number: K101083
·
Decision Jul 2, 2010
Classifications
1
FEI Numbers
44
Registration Numbers
44
Same Product Code
21
Applicant Total
11
Review Days
74
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- DSS STABILIZATION SYSTEM
- K Number
- K101083
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 888.3070
- Medical Specialty
- Orthopedic
- Decision
- Unknown
- Statement or Summary
- Summary
- Applicant
- Paradigm Spine, LLC
- Date Received
- April 19, 2010
- Decision Date
- July 2, 2010
- Product Code
- NQP
- 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 |
|---|---|---|---|
| NQP | Posterior Metal/Polymer Spinal System, Fusion | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (NQP), ordered by most recent decision date.
CD HORIZON Spinal System
FDA 510(k)
FDA Class 2
·Orthopedic
CD Horizon Astute Spinal System
FDA 510(k)
FDA Class 2
·Orthopedic
CD Horizon Spinal System
FDA 510(k)
FDA Class 2
·Orthopedic
DYNESYS TOP-LOADING SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
ZIMMER DTO PIN PRESS INSTRUMENT
FDA 510(k)
FDA Class 2
·Orthopedic
DYNESYS TOP-LOADING SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Other Clearances by Paradigm Spine, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K153302 | coflex-IF | Sep 8, 2016 | Substantially Equivalent |
| K120491 | DSS STABILIZATION SYSTEM-RIGID | May 9, 2012 | Unknown |
| 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 |
| 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 |