FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇪 Ireland
Actis DuoFix Hip Prosthesis- Collarless
K Number: K210581
·
Decision May 20, 2021
Classifications
1
FEI Numbers
189
Registration Numbers
189
Same Product Code
158
Applicant Total
48
Review Days
83
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Basic Information
- Device Name
- Actis DuoFix Hip Prosthesis- Collarless
- K Number
- K210581
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3353
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Depuy Ireland UC
- Date Received
- February 26, 2021
- Decision Date
- May 20, 2021
- Product Code
- MEH
- 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 |
|---|---|---|---|
| MEH | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | FDA class 2 | Orthopedic |
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