FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
VERTECEM II CEMENT KIT
K Number: K121876
·
Decision Oct 19, 2012
Classifications
1
FEI Numbers
114
Registration Numbers
114
Same Product Code
107
Applicant Total
2
Review Days
114
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Basic Information
- Device Name
- VERTECEM II CEMENT KIT
- K Number
- K121876
- 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
- June 27, 2012
- Decision Date
- October 19, 2012
- 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 | ||
|---|---|---|---|
| K090460 | BONOS INJECT | Apr 14, 2009 | Substantially Equivalent |