OCJClass I

Spinal Channeling Instrument, Vertebroplasty

Orthopedic · 21 CFR 888.4540

Create channels in the existing spinal bone structure for the flow of polymethylmethacrylate bone cement (PMMA) prior to a vertebroplasty procedure. Treatment of pathological compression fractures of the vertebral body that may result from osteoporosis, benign lesions, and/or malignant lesions.

MDR events20All time

Recalls2All time

Registered firms48Currently listed

510(k) clearances1All time

Recent MDR events

20 adverse event reports on file

Event type breakdown

Malfunction18

Unspecified1

Injury1

Most-reported manufacturers

Stryker Instruments-a Division Of Stryker Corp10 Benvenue Medical, Inc.2 Stryker Instruments-kalamazoo2 Benvenue Medical1 Izi Medical Products1 Kyphon -medtronic Spine Llc1 Kyphon, Inc.1 Stryker Corporation1

Recalls

2 recall events for this product code

Registered firms

48 firms currently registered for this product code

510(k) clearances

1 clearances for this product code

Benvenue Medical, Inc.Jul 10, 2007
K070293 · BENVENUE VCF OSTEO COIL SYSTEM