510(k) K103816
K103816 is an FDA 510(k) premarket notification submitted by Teknimed Sas for the device "COHESION BONE CEMENT". The FDA issued a decision of Substantially Equivalent on February 4, 2011. The device falls under product code NDN (Cement, Bone, Vertebroplasty), a Class II device regulated under 21 CFR 888.3027. Teknimed Sas has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 4, 2011
- Date Received
- December 29, 2010
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cement, Bone, Vertebroplasty
- Device Class
- Class II
- Regulation Number
- 888.3027
- Review Panel
- OR
- Submission Type