510(k) K192394
K192394 is an FDA 510(k) premarket notification submitted by Osartis GmbH for the device "Hi-Fatigue Bone Cement". The FDA issued a decision of Substantially Equivalent on December 2, 2019. The device falls under product code LOD (Bone Cement), a Class II device regulated under 21 CFR 888.3027. Osartis GmbH has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 2, 2019
- Date Received
- September 3, 2019
- 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