FDA Clears 13 Orthopedic Devices in September
The FDA issued 13 orthopedic-related 510(k) clearances in September, according to a report by the FDA.
The devices include the following:
1. AngleFix T Locking Plate from AngleFix Tech.
2. Aptus K-Wire System from Medartis.
3. Dorado Wide Intervertebral Body Cage from SpineFrontier.
4. Equivabone Osteoinductive Bone Graft Substitute from Etex.
5. Freedom Total Knee Cruciate Retaining Femoral Component from Maxx Orthopedics.
6. KneeAlign System from OrthAlign.
7. Osteoselect Demineralized Bone Matrix Putty from Bacterin.
8. PCT Spinal System from Gold Standard Orthopaedics.
9. Peek CF Interference Screw from Parcus Medical.
10. Robotic Arm Interactive Orthopedic System from Mako Surgical.
11. Spinal Foraminoscope from Blazejewski Medi-Tech.
12. Tryptik CA Anterior Intersomatic Cervical Cage from Spineart.
13. V-Lox Peek Suture Anchor from Parcus Medical.
Read the FDA's report on September 2009 510(k) clearances.
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