FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
BonOs HV Genta, BonOs MV Genta, BonOs LV Genta
K Number: K210125
·
Decision Mar 19, 2021
Classifications
1
FEI Numbers
81
Registration Numbers
81
Same Product Code
70
Applicant Total
3
Review Days
59
Basic Information
- Device Name
- BonOs HV Genta, BonOs MV Genta, BonOs LV Genta
- K Number
- K210125
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3027
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- OSARTIS GmbH
- Date Received
- January 19, 2021
- Decision Date
- March 19, 2021
- Product Code
- LOD
- 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 |
|---|---|---|---|
| LOD | Bone Cement | FDA class 2 | Orthopedic |
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