510(k) K121876
K121876 is an FDA 510(k) premarket notification submitted by Aap Biomaterials GmbH for the device "VERTECEM II CEMENT KIT". The FDA issued a decision of Substantially Equivalent on Oct 19, 2012. The device falls under product code NDN (Cement, Bone, Vertebroplasty), a Class II device regulated under 21 CFR 888.3027. Aap Biomaterials GmbH has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 19, 2012
- Date Received
- Jun 27, 2012
- Clearance Type
- Abbreviated
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cement, Bone, Vertebroplasty
- Device Class
- Class II
- Regulation Number
- 888.3027
- Review Panel
- OR
- Submission Type
- 510(k)