FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
BONOS R 1X20, BONOS R 2X20, BONOS R 1X40, BONOS R 2X40, BONOS R 1X60
K Number: K123225
·
Decision Mar 15, 2013
Classifications
1
FEI Numbers
82
Registration Numbers
82
Same Product Code
71
Applicant Total
2
Review Days
151
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Basic Information
- Device Name
- BONOS R 1X20, BONOS R 2X20, BONOS R 1X40, BONOS R 2X40, BONOS R 1X60
- K Number
- K123225
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 888.3027
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Aap Biomaterials GmbH & Co. KG
- Date Received
- October 15, 2012
- Decision Date
- March 15, 2013
- 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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Other Clearances by Aap Biomaterials GmbH & Co. KG
| K Number | Device Name | ||
|---|---|---|---|
| K123081 | BONOS R GENTA 1X20 MODEL 01-0228; BONOS R GENTA 2X20 MODEL 01-0229; BONOS R GENTA 1X40 MODEL 01-0217; BONOS R GENTA 2X40 | Mar 7, 2013 | Substantially Equivalent |