FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
BONOS INJECT
K Number: K090460
·
Decision Apr 14, 2009
Classifications
1
FEI Numbers
114
Registration Numbers
114
Same Product Code
107
Applicant Total
2
Review Days
50
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Basic Information
- Device Name
- BONOS INJECT
- K Number
- K090460
- 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
- Date Received
- February 23, 2009
- Decision Date
- April 14, 2009
- Product Code
- NDN
- 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 |
|---|---|---|---|
| NDN | Cement, Bone, Vertebroplasty | FDA class 2 | Orthopedic |
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Other Clearances by Aap Biomaterials GmbH
| K Number | Device Name | ||
|---|---|---|---|
| K121876 | VERTECEM II CEMENT KIT | Oct 19, 2012 | Substantially Equivalent |