510(k) K210607
K210607 is an FDA 510(k) premarket notification submitted by Heraeus Medical GmbH for the device "PALACOS R pro, PALACOS R+G pro, PALACOS MV+G pro". The FDA issued a decision of Substantially Equivalent on July 9, 2021. 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
- July 9, 2021
- Date Received
- March 1, 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