510(k) K050085
K050085 is an FDA 510(k) premarket notification submitted by Heraeus Kulzer,GmbH for the device "OSTEOPAL V". The FDA issued a decision of Substantially Equivalent on September 14, 2005. The device falls under product code LOD (Bone Cement), a Class II device regulated under 21 CFR 888.3027. Heraeus Kulzer,GmbH has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 14, 2005
- Date Received
- January 13, 2005
- Clearance Type
- Abbreviated
- 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