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).

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
No devices found for this product code.

About Product Code OAR - Regulatory Context