FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
DYNESYS SPINAL SYSTEM
K Number: K031511
·
Decision Mar 5, 2004
Classifications
1
FEI Numbers
44
Registration Numbers
44
Same Product Code
21
Applicant Total
4
Review Days
296
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Basic Information
- Device Name
- DYNESYS SPINAL SYSTEM
- K Number
- K031511
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3070
- Medical Specialty
- Orthopedic
- Decision
- Unknown
- Statement or Summary
- Summary
- Applicant
- Centerpulse Spine-Tech, Inc.
- Date Received
- May 14, 2003
- Decision Date
- March 5, 2004
- 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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