FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
4S SPINAL SYSTEM
K Number: K063708
·
Decision Apr 24, 2007
Classifications
1
FEI Numbers
342
Registration Numbers
342
Same Product Code
302
Applicant Total
3
Review Days
132
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Basic Information
- Device Name
- 4S SPINAL SYSTEM
- K Number
- K063708
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3070
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Taeyeon Medical Co., Ltd.
- Date Received
- December 13, 2006
- Decision Date
- April 24, 2007
- 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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