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510(k) K994022

PARALLAX CRANIOSET by Parallax Medical, Inc. — Product Code GXP

K994022 is an FDA 510(k) premarket notification submitted by Parallax Medical, Inc. for the device "PARALLAX CRANIOSET". The FDA issued a decision of Substantially Equivalent on August 31, 2000. The device falls under product code GXP (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
August 31, 2000
Date Received
November 26, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
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)
  • K023445 — TRACERS BONE CEMENT OPACIFIER (March 11, 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)
  • K991893 — PARALLAX TRACER RADIOPAQUE PARTICLES (August 13, 1999)

Other clearances for product code GXP

  • K251959 — TnR Cranial Implant (July 30, 2026)
  • K261265 — Permatage XT Settable Bone Putty (June 15, 2026)
  • K253732 — Permatage Flowable, Settable Bone Paste (March 13, 2026)
  • K253854 — MONTAGE XT Cranial Cement (January 2, 2026)
  • K241027 — Permatage Settable Bone Putty (September 26, 2024)
  • K232771 — Montage Flowable Settable, Resorbable Bone Paste (February 16, 2024)
  • K231475 — MONTAGE-QS Settable, Resorbable Bone Putty (October 12, 2023)
  • K221933 — MONTAGE Settable, Resorbable Bone Putty (January 13, 2023)
  • K182742 — DB-CMF (June 20, 2019)
  • K162864 — OsteoVation Impact (January 13, 2017)

FDA data resources