510(k) K213812
K213812 is an FDA 510(k) premarket notification submitted by Heraeus Medical GmbH for the device "PALACOS MV pro". The FDA issued a decision of Substantially Equivalent on February 2, 2022. 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
- February 2, 2022
- Date Received
- December 7, 2021
- Clearance Type
- Traditional
- 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