FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DSS STABILIZATION SYSTEM
K Number: K080963
·
Decision May 2, 2008
Classifications
1
FEI Numbers
44
Registration Numbers
44
Same Product Code
21
Applicant Total
3
Review Days
28
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Basic Information
- Device Name
- DSS STABILIZATION SYSTEM
- K Number
- K080963
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 888.3070
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Paradigm Spine
- Date Received
- April 4, 2008
- Decision Date
- May 2, 2008
- 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 |
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