510(k) K063606
K063606 is an FDA 510(k) premarket notification submitted by Spine Wave, Inc. for the device "MODIFICATION TO STAXX FX SYSTEM". The FDA issued a decision of Substantially Equivalent on April 13, 2007. The device falls under product code OBL (Cement, Bone, Pre-Formed, Modular, Polymeric, Vertebroplasty), a Class II device regulated under 21 CFR 888.3027. Spine Wave, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 13, 2007
- Date Received
- December 1, 2006
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cement, Bone, Pre-Formed, Modular, Polymeric, Vertebroplasty
- Device Class
- Class II
- Regulation Number
- 888.3027
- Review Panel
- OR
- Submission Type
Reduction of vertebral body fractures in conjunction with PMMA bone cement cleared for vertebroplasty and restoration of vertebral body height.