510(k) K070293
K070293 is an FDA 510(k) premarket notification submitted by Benvenue Medical, Inc. for the device "BENVENUE VCF OSTEO COIL SYSTEM". The FDA issued a decision of Substantially Equivalent on July 10, 2007. The device falls under product code OCJ (Spinal Channeling Instrument, Vertebroplasty), a Class I device regulated under 21 CFR 888.4540. Benvenue Medical, Inc. has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 10, 2007
- Date Received
- January 31, 2007
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Spinal Channeling Instrument, Vertebroplasty
- Device Class
- Class I
- Regulation Number
- 888.4540
- Review Panel
- OR
- Submission Type
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.