510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K051820Substantially Equivalent

Parallax Ezflow Cement Delivery System

ArthroCare Corporation, Sunnyvale CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K051820 is the FDA 510(k) clearance record for PARALLAX EZFLOW CEMENT DELIVERY SYSTEM, a class I device, cleared for Arthrocare Corp. on under FDA product code OAR (Injector, Vertebroplasty (Does Not Contain Cement)). FDA's definition for product code OAR reads: "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...". FDA records list 149 510(k) clearances for Arthrocare Corp., from to . As of , FDA records show no recalls naming K051820.

Clearance record

Decision date
Received
(63 days to decision)
Product code
OAR Injector, Vertebroplasty (Does Not Contain Cement)
Regulation
21 CFR 888.4200
Device class
Class I
Review panel
Orthopedic
Applicant
Arthrocare Corp. 680 Vaqueros Ave., Sunnyvale CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OAR

Trailing 12 months

FDA records hold no clearances under product code OAR in the trailing twelve months.

FDA records show no clearances under product code OAR in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code OAR, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260