Benvenue VCF Osteo Coil System
FDA 510(k) K070293 · Benvenue Medical, Inc.
510(k) numberK070293
Submission
- Device name
- Benvenue VCF Osteo Coil System
- Applicant
- Benvenue Medical, Inc.
Mountain View, CA, US - Received
- January 31, 2007
- Decision date
- July 10, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OCJ – Spinal Channeling Instrument, Vertebroplasty
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 888.4540
- Specialty
- 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.
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Questions and answers
When was Benvenue VCF Osteo Coil System cleared by the FDA?
Benvenue VCF Osteo Coil System (K070293) received a 510(k) decision of Substantially Equivalent on July 10, 2007, 160 days after the submission was received.
What is the product code of K070293?
The FDA product code is OCJ – Spinal Channeling Instrument, Vertebroplasty, a Class I (low risk) device regulated under 21 CFR 888.4540.