510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
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K023445Substantially Equivalent

Tracers Bone Cement Opacifier

Parallax Medical, Inc., Scotts Valley CA / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K023445 is the FDA 510(k) clearance record for TRACERS BONE CEMENT OPACIFIER, a class II device, cleared for Parallax Medical, Inc. on under FDA product code MYU (Accessory, Barium Sulfate, Methyl Methacrylate For Cranioplasty). FDA records list 6 510(k) clearances for Parallax Medical, Inc., from to . As of , FDA records show no recalls naming K023445.

Clearance record

Decision date
Received
(147 days to decision)
Product code
MYU Accessory, Barium Sulfate, Methyl Methacrylate For Cranioplasty
Regulation
21 CFR 882.5300
Device class
Class II
Review panel
Neurology
Applicant
Parallax Medical, Inc. 940 Disc Dr., Scotts Valley CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MYU

Trailing 12 months

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

FDA records show no clearances under product code MYU in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code MYU, 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