FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
T2 Alpha Femur Antegrade GT/PF Nailing System, T2 Alpha Tibia Nailing System, IMN Screws System, IMN Instruments System
K Number: K191271
·
Decision Jun 11, 2019
Classifications
1
FEI Numbers
295
Registration Numbers
295
Same Product Code
505
Applicant Total
3
Review Days
29
Basic Information
- Device Name
- T2 Alpha Femur Antegrade GT/PF Nailing System, T2 Alpha Tibia Nailing System, IMN Screws System, IMN Instruments System
- K Number
- K191271
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 888.3020
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Stryker Trauma Gmbh
- Date Received
- May 13, 2019
- Decision Date
- June 11, 2019
- 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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