Home / 510(k) Clearances / K042414

510(k) K042414

VISIOPLAST ACRYLIC RESIN by Tecres — Product Code GXP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 29, 2004
Date Received
September 7, 2004
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 Tecres

  • K252326 — InterSpace GV Hip Spacer (August 6, 2025)
  • K211163 — Bone Cement Genta, Bone Cement HV, Bone Cement LV (January 9, 2023)
  • K220131 — KYPHON VuE Bone Cement (April 18, 2022)
  • K181732 — InterSpace Knee Extra-Large Size, InterSpace Knee ATS (April 27, 2019)
  • K122175 — MENDEC SPINE HV, MENDEC SPINE HV SYSTEM (March 28, 2013)
  • K112983 — SPACER-S (December 12, 2011)
  • K101356 — Spacer-G and Spacer-K (September 20, 2011)
  • K092773 — CEMEX GENTA, GENTA SYSTEM AND GENTA SYSTEM FAST (November 24, 2009)
  • K062273 — SPACER-G TEMPORARY HIP PROSTHESIS (May 22, 2008)
  • K062274 — SPACER-K TEMPORARY KNEE SPACER WITH GENTAMICIN, MODELS SPK0021, SPK0121, SPK0221 (May 22, 2008)

Other clearances for product code GXP

  • 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)
  • K143661 — DirectInject (September 2, 2015)
  • K102018 — NORIAN REINFORCED, NORIAN REINFORCED FAST SET PUTTY (September 23, 2010)