FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
MUTARS Cemented Femoral Stems
K Number: K200045
·
Decision Oct 16, 2020
Classifications
1
FEI Numbers
189
Registration Numbers
189
Same Product Code
158
Applicant Total
20
Review Days
282
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Basic Information
- Device Name
- MUTARS Cemented Femoral Stems
- K Number
- K200045
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3353
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Implantcast GmbH
- Date Received
- January 8, 2020
- Decision Date
- October 16, 2020
- 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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