510(k) K080873
K080873 is an FDA 510(k) premarket notification submitted by Teknimed, S.A. for the device "OPACITY + BONE CEMENT". The FDA issued a decision of Substantially Equivalent on August 28, 2008. The device falls under product code NDN (Cement, Bone, Vertebroplasty), a Class II device regulated under 21 CFR 888.3027. Teknimed, S.A. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 28, 2008
- Date Received
- March 31, 2008
- 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