Spinal Channeling Instrument, Vertebroplasty
FDA product code OCJ · Class I (low risk) · 21 CFR 888.4540 · Orthopedic
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.
1510(k) clearances
0PMA approvals
2recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K070293 | Benvenue VCF Osteo Coil SystemOCJ · Traditional | Benvenue Medical, Inc. | 07/10/2007SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2103-2011 | Confidence Introducer Needle Side Hole 13G x 4-Inch Product Code: 2839-04-413 The…Mislabeled: Package labeled (11g x 6 inch) contains a 13g x 4-inch side hole needle | DePuy Spine, Inc. | 03/22/2011Terminated |
| Z-2102-2011 | Confidence Diamond Tip Introducer Needle 11G x 6-Inch Product Code: 2839-03-611 The…Mislabeled: Package labeled (11g x 6 inch) contains a 13g x 4-inch side hole needle | DePuy Spine, Inc. | 03/22/2011Terminated |