FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
DYNA LOCKING ANKLE NAIL
K Number: K120419
·
Decision May 21, 2012
Classifications
1
FEI Numbers
295
Registration Numbers
295
Same Product Code
505
Applicant Total
12
Review Days
101
Basic Information
- Device Name
- DYNA LOCKING ANKLE NAIL
- K Number
- K120419
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3020
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- U&I CORP.
- Date Received
- February 10, 2012
- Decision Date
- May 21, 2012
- Product Code
- HSB
- 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 |
|---|---|---|---|
| HSB | Rod, Fixation, Intramedullary And Accessories | FDA class 2 | Orthopedic |
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