FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
MODIFICATION TO GLOBAL SPINAL FIXATION SYSTEM
K Number: K042928
·
Decision Feb 17, 2005
Classifications
1
FEI Numbers
338
Registration Numbers
338
Same Product Code
308
Applicant Total
12
Review Days
118
Basic Information
- Device Name
- MODIFICATION TO GLOBAL SPINAL FIXATION SYSTEM
- K Number
- K042928
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 888.3070
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- U&I CORP.
- Date Received
- October 22, 2004
- Decision Date
- February 17, 2005
- Product Code
- MNH
- 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 |
|---|---|---|---|
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | FDA class 2 | Orthopedic |
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