FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
PERFIX SPINAL SYSTEM, MODEL SNA4530-9610, SNM4530-9610, SN3020 (TOTAL: 549)
K Number: K091725
·
Decision Nov 9, 2009
Classifications
1
FEI Numbers
338
Registration Numbers
338
Same Product Code
308
Applicant Total
12
Review Days
151
Basic Information
- Device Name
- PERFIX SPINAL SYSTEM, MODEL SNA4530-9610, SNM4530-9610, SN3020 (TOTAL: 549)
- K Number
- K091725
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3070
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- U&I CORP.
- Date Received
- June 11, 2009
- Decision Date
- November 9, 2009
- 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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