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Cement, Bone, Pre-Formed, Modular, Polymeric, Vertebroplasty

FDA product code OBL · 1 cleared devices

Class 2 Orthopedic
Regulation
21 CFR 888.3027
Review panel
OR
Implant
Yes
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2007-04-13 – 2007-04-13

Reduction of vertebral body fractures in conjunction with PMMA bone cement cleared for vertebroplasty and restoration of vertebral body height.

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