FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
T2 FEMORAL NAIL MODEL 1825-XXXXCP, 1828-XXXXCP
K Number: K112059
·
Decision Aug 8, 2011
Classifications
1
FEI Numbers
295
Registration Numbers
295
Same Product Code
505
Applicant Total
86
Review Days
20
Basic Information
- Device Name
- T2 FEMORAL NAIL MODEL 1825-XXXXCP, 1828-XXXXCP
- K Number
- K112059
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 888.3020
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Stryker
- Date Received
- July 19, 2011
- Decision Date
- August 8, 2011
- 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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