FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
ULC SPINAL PEDICLE SCREW SYSTEM
K Number: K083077
·
Decision Oct 26, 2009
Classifications
1
FEI Numbers
326
Registration Numbers
326
Same Product Code
308
Applicant Total
3
Review Days
375
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Basic Information
- Device Name
- ULC SPINAL PEDICLE SCREW SYSTEM
- K Number
- K083077
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3070
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Otis Biotech Co., Ltd.
- Date Received
- October 16, 2008
- Decision Date
- October 26, 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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