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510(k) K023445

TRACERS BONE CEMENT OPACIFIER by Parallax Medical, Inc. — Product Code MYU

K023445 is an FDA 510(k) premarket notification submitted by Parallax Medical, Inc. for the device "TRACERS BONE CEMENT OPACIFIER". The FDA issued a decision of Substantially Equivalent on March 11, 2003. The device falls under product code MYU (Accessory, Barium Sulfate, Methyl Methacrylate For Cranioplasty), a Class II device regulated under 21 CFR 882.5300. Parallax Medical, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 11, 2003
Date Received
October 15, 2002
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Accessory, Barium Sulfate, Methyl Methacrylate For Cranioplasty
Device Class
Class II
Regulation Number
882.5300
Review Panel
NE
Submission Type

Other clearances by Parallax Medical, Inc.

  • K033230 — TRACERS TA BONE CEMENT OPACIFIER, MODEL TCR-TA (December 12, 2003)
  • K022169 — CLEARVIEW PLUS BONE AND VERTEBRAL BODY BIOPSY NEEDLES (July 25, 2002)
  • K011206 — PARALLAX BONE AND VERTEBRAL BODY BIOPSY AND INFUSION NEEDLES (July 18, 2001)
  • K994022 — PARALLAX CRANIOSET (August 31, 2000)
  • K991893 — PARALLAX TRACER RADIOPAQUE PARTICLES (August 13, 1999)

Other clearances for product code MYU

  • K033230 — TRACERS TA BONE CEMENT OPACIFIER, MODEL TCR-TA (December 12, 2003)
  • K032388 — BONE CEMENT RADIO-OPACIFIER (October 31, 2003)
  • K024359 — VISTA SCIENTIFIC BARIUM SULFATE, MODEL 3001-1 (August 8, 2003)
  • K002063 — BIOTRACE, MODEL 1730 (August 10, 2000)
  • K991893 — PARALLAX TRACER RADIOPAQUE PARTICLES (August 13, 1999)

FDA data resources