Modification to Staxx FX System
FDA 510(k) K063606 · Spine Wave, Inc.
510(k) numberK063606
Submission
- Device name
- Modification to Staxx FX System
- Applicant
- Spine Wave, Inc.
Shelton, CT, US - Received
- December 1, 2006
- Decision date
- April 13, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OBL – Cement, Bone, Pre-Formed, Modular, Polymeric, Vertebroplasty
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3027
- Specialty
- Orthopedic
- Implant
- Yes
Reduction of vertebral body fractures in conjunction with PMMA bone cement cleared for vertebroplasty and restoration of vertebral body height.
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Questions and answers
When was Modification to Staxx FX System cleared by the FDA?
Modification to Staxx FX System (K063606) received a 510(k) decision of Substantially Equivalent on April 13, 2007, 133 days after the submission was received.
What is the product code of K063606?
The FDA product code is OBL – Cement, Bone, Pre-Formed, Modular, Polymeric, Vertebroplasty, a Class II (moderate risk) device regulated under 21 CFR 888.3027.