510(k) K133907
K133907 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 January 22, 2014. 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
- January 22, 2014
- Date Received
- December 23, 2013
- Clearance Type
- Special
- 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