510(k) K120956
K120956 is an FDA 510(k) premarket notification submitted by Medical Modeling, Inc. for the device "VSP SYSTEM". The FDA issued a decision of Substantially Equivalent on December 12, 2012. The device falls under product code DZJ (Driver, Wire, And Bone Drill, Manual), a Class II device regulated under 21 CFR 872.4120. Medical Modeling, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 12, 2012
- Date Received
- March 30, 2012
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Driver, Wire, And Bone Drill, Manual
- Device Class
- Class II
- Regulation Number
- 872.4120
- Review Panel
- DE
- Submission Type