Injector, Vertebroplasty (Does Not Contain Cement)
The Injector, Vertebroplasty (Does Not Contain Cement) (product code OAR) is a Class 1 orthopedic device intended for the injection of vertebroplasty bone cement during vertebroplasty or kyphoplasty procedures for the fixation of pathological vertebral compression fractures resulting from osteoporosis, benign lesions such as hemangioma, or malignant lesions such as metastatic cancers or myeloma. Regulated under 21 CFR 888.4200 within the Orthopedic specialty, it is subject to general controls and exempt from 510(k) requirements but not GMP-exempt. The device carries no implant or life-sustaining flags.
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Basic Information
- Product Code
- OAR
- Device Class
- FDA class 1
- Regulation Number
- 888.4200
- Medical Specialty
- Orthopedic
- Review Panel
- OR
- Submission Type
- 4
Device Characteristics
Definition
Intended for injection of vertebroplasty bone cement for the fixation of pathological fractures of the vertebral body using vertebroplasty or kyphoplasty procedures. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma).
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 |
|---|---|---|---|---|
| K051820 | PARALLAX EZFLOW CEMENT DELIVERY SYSTEM | Sep 06, 2005 | Substantially Equivalent | Arthrocare Corp. |
FEI Numbers
This FDA classification entry is associated with 70 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 70 registration numbers. Click on an entry to view related FDA registrations.