FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TSRH SPINAL SYSTEM
K Number: K032578
·
Decision Sep 17, 2003
Classifications
1
FEI Numbers
354
Registration Numbers
354
Same Product Code
302
Applicant Total
96
Review Days
27
Basic Information
- Device Name
- TSRH SPINAL SYSTEM
- K Number
- K032578
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 888.3070
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- MEDTRONIC SOFAMOR DANEK, INC.
- Date Received
- August 21, 2003
- Decision Date
- September 17, 2003
- Product Code
- MNI
- 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 |
|---|---|---|---|
| MNI | Orthosis, Spinal Pedicle Fixation | FDA class 2 | Orthopedic |
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