OAR · Class I · 21 CFR 888.4200

FDA Product Code OAR: Injector, Vertebroplasty (does Not Contain Cement)

Intended For Injection Of Vertebroplasty Bone Cement For The Fixation Of Pathological Fractures Of The Vertebral Body Using Vertebroplasty Or Kyphoplasty Procedures. Painful Vertebral Compression Fractures May Result From Osteoporosis, Benign Lesions (hemangioma), And Malignant Lesions (metastatic Cancers, Myeloma).

Leading manufacturers include Arthrocare Corp..

1
Total
1
Cleared
63d
Avg days
2005
Since

FDA 510(k) Cleared Injector, Vertebroplasty (does Not Contain Cement) Devices (Product Code OAR)

1 devices
1–1 of 1
Cleared Sep 06, 2005
PARALLAX EZFLOW CEMENT DELIVERY SYSTEM
K051820
Arthrocare Corp.
Orthopedic · 63d

About Product Code OAR - Regulatory Context