K070293 is an FDA 510(k) clearance for the BENVENUE VCF OSTEO COIL SYSTEM. This device is classified as a Spinal Channeling Instrument, Vertebroplasty (Class I - General Controls, product code OCJ).
Submitted by Benvenue Medical, Inc. (Mountain View, US). The FDA issued a Cleared decision on July 10, 2007, 160 days after receiving the submission on January 31, 2007.
This device falls under the Orthopedic FDA review panel. Regulated under 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..
| 510(k) Number | K070293 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 31, 2007 |
| Decision Date | July 10, 2007 |
| Days to Decision | 160 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | OCJ - Spinal Channeling Instrument, Vertebroplasty |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 888.4540 |
| Definition | 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. |