510(k) K101930
K101930 is an FDA 510(k) premarket notification submitted by Memometal Technologies for the device "MEMOMETAL NAVIS BONE PLATING SYSTEM". The FDA issued a decision of Substantially Equivalent on Mar 15, 2011. The device falls under product code HRS (Plate, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. Memometal Technologies has 9 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 15, 2011
- Date Received
- Jul 9, 2010
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Plate, Fixation, Bone
- Device Class
- Class II
- Regulation Number
- 888.3030
- Review Panel
- OR
- Submission Type
- 510(k)