FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
Implantcast ic-Bipolar Head System
K Number: K191569
·
Decision Aug 28, 2019
Classifications
1
FEI Numbers
216
Registration Numbers
216
Same Product Code
98
Applicant Total
20
Review Days
76
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Basic Information
- Device Name
- Implantcast ic-Bipolar Head System
- K Number
- K191569
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3390
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Implantcast GmbH
- Date Received
- June 13, 2019
- Decision Date
- August 28, 2019
- Product Code
- KWY
- 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 |
|---|---|---|---|
| KWY | Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | FDA class 2 | Orthopedic |
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