510(k) K070033
K070033 is an FDA 510(k) premarket notification submitted by Memometal Technologies for the device "MEMOMETAL VARISATION, MODELS AV26-08, AV26-10, AV90-08 AND AV90-10". The FDA issued a decision of Substantially Equivalent on Mar 19, 2007. The device falls under product code JDR (Staple, 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 19, 2007
- Date Received
- Jan 3, 2007
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Staple, Fixation, Bone
- Device Class
- Class II
- Regulation Number
- 888.3030
- Review Panel
- OR
- Submission Type
- 510(k)