510(k) K153737
K153737 is an FDA 510(k) premarket notification submitted by Heraeus Medical GmbH for the device "OSTEOPAL plus". The FDA issued a decision of Substantially Equivalent on April 22, 2016. The device falls under product code LOD (Bone Cement), a Class II device regulated under 21 CFR 888.3027. Heraeus Medical GmbH has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 22, 2016
- Date Received
- December 28, 2015
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Bone Cement
- Device Class
- Class II
- Regulation Number
- 888.3027
- Review Panel
- OR
- Submission Type