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510(k) K032685

CEMSTOP CEMENT RESTRICTOR by Teknimed, S.A. — Product Code LZN

K032685 is an FDA 510(k) premarket notification submitted by Teknimed, S.A. for the device "CEMSTOP CEMENT RESTRICTOR". The FDA issued a decision of Substantially Equivalent on November 26, 2003. The device falls under product code LZN (Cement Obturator), a Class II device regulated under 21 CFR 878.3300. Teknimed, S.A. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 26, 2003
Date Received
August 29, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cement Obturator
Device Class
Class II
Regulation Number
878.3300
Review Panel
OR
Submission Type

Other clearances by Teknimed, S.A.

  • K242216 — GENTAFIX® (1, 3, 3MV) (December 18, 2024)
  • K230394 — EUROSCREW NG; EUROSCREW TCP NG (May 12, 2023)
  • K161114 — HIGH V+ (April 12, 2017)
  • K103816 — COHESION BONE CEMENT (February 4, 2011)
  • K103433 — F20 (January 3, 2011)
  • K090435 — VERTECEM (December 21, 2009)
  • K083005 — NANGEL (March 4, 2009)
  • K080873 — OPACITY + BONE CEMENT (August 28, 2008)
  • K062102 — ODONCER (April 16, 2007)
  • K043593 — SPINE-FIX BIOMIMETIC BONE CEMENT (March 17, 2006)

Other clearances for product code LZN

  • K220838 — Artisan Bone Plug, Universal Cement Restrictor (May 20, 2022)
  • K061824 — TORNIER CEMENT RESTRICTOR (September 14, 2006)
  • K023680 — BIOBUCK CEMENT RESTRICTOR (November 19, 2002)
  • K011943 — IMPRO VISE ABSORBABLE CEMENT FLOW RESTRICTOR (September 19, 2001)
  • K010840 — SYNPLUG (April 20, 2001)
  • K000587 — SHUTTLE STOP (May 4, 2000)
  • K993841 — CEMSTOP CEMENT RESTRICTOR (May 4, 2000)
  • K992462 — OSTEONICS UNIVERSAL DISTAL CEMENT PLUG (August 13, 1999)
  • K972411 — LINK CEMENT PLUG (August 29, 1997)
  • K970779 — OSTEONICS TIBIAL TRAY SCREW HOLE PLUGS (May 9, 1997)

FDA data resources