510(k) K063453
K063453 is an FDA 510(k) premarket notification submitted by Elite Surgical Supplies (Pty), Ltd. for the device "VERTEFIX PEDICLE SCREW SPINAL SYSTEM". The FDA issued a decision of Substantially Equivalent on Aug 30, 2007. The device falls under product code MNI (Orthosis, Spinal Pedicle Fixation), a Class II device regulated under 21 CFR 888.3070. Elite Surgical Supplies (Pty), Ltd. has 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 30, 2007
- Date Received
- Nov 15, 2006
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Orthosis, Spinal Pedicle Fixation
- Device Class
- Class II
- Regulation Number
- 888.3070
- Review Panel
- OR
- Submission Type
- 510(k)