510(k) K051820
K051820 is an FDA 510(k) premarket notification submitted by Arthrocare Corp. for the device "PARALLAX EZFLOW CEMENT DELIVERY SYSTEM". The FDA issued a decision of Substantially Equivalent on September 6, 2005. The device falls under product code OAR (Injector, Vertebroplasty (Does Not Contain Cement)), a Class I device regulated under 21 CFR 888.4200. Arthrocare Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 6, 2005
- Date Received
- July 5, 2005
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Injector, Vertebroplasty (Does Not Contain Cement)
- Device Class
- Class I
- Regulation Number
- 888.4200
- Review Panel
- OR
- Submission Type
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).