Spinal Channeling Instrument, Vertebroplasty
The Vertebroplasty Spinal Channeling Instrument (product code OCJ) is an orthopedic surgical instrument used to create channels in the existing spinal bone structure to facilitate the flow of polymethylmethacrylate (PMMA) bone cement prior to a vertebroplasty procedure, indicated for the treatment of pathological compression fractures of the vertebral body resulting from osteoporosis, benign lesions, or malignant lesions. This device is FDA Class 1 under regulation 888.4540 in the Orthopedic specialty, subject only to general controls; it is not GMP-exempt despite its lower risk classification. It carries no implant or life-sustaining flags.
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Basic Information
- Product Code
- OCJ
- Device Class
- FDA class 1
- Regulation Number
- 888.4540
- Medical Specialty
- Orthopedic
- Review Panel
- OR
- Submission Type
- 4
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K070293 | BENVENUE VCF OSTEO COIL SYSTEM | Jul 10, 2007 | Substantially Equivalent | Benvenue Medical, Inc. |
FEI Numbers
This FDA classification entry is associated with 48 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 48 registration numbers. Click on an entry to view related FDA registrations.