510(k) K170802
K170802 is an FDA 510(k) premarket notification submitted by Synthes (USA) Products, LLC for the device "TRAUMACEM V+ Injectable Bone Cement". The FDA issued a decision of Substantially Equivalent on Sep 28, 2017. The device falls under product code LOD (Bone Cement), a Class II device regulated under 21 CFR 888.3027. Synthes (USA) Products, LLC has 44 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 28, 2017
- Date Received
- Mar 17, 2017
- 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
- 510(k)