FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇪 Ireland
Pro-X1 Trochanteric Nailing System
K Number: K221621
·
Decision Mar 6, 2023
Classifications
1
FEI Numbers
302
Registration Numbers
302
Same Product Code
528
Applicant Total
1
Review Days
276
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Basic Information
- Device Name
- Pro-X1 Trochanteric Nailing System
- K Number
- K221621
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3020
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- X-Bolt Orthopedics
- Date Received
- June 3, 2022
- Decision Date
- March 6, 2023
- 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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