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510(k) K943727

BIOSTOP G BONE CEMENT RESTRICTOR by Landos, Inc. — Product Code LZN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 11, 1995
Date Received
August 2, 1994
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 Landos, Inc.

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  • K971070 — SCARF THREAD-HEAD (TM) HEAD SCREW (July 9, 1997)
  • K971069 — TWIST-OFF (TM) SCREW (July 9, 1997)
  • K961732 — KAR (July 8, 1997)
  • K970846 — 22.2/+4MM CO CR & ZIRCONIA FEMORAL HEAD (June 5, 1997)
  • K953111 — CORAIL (December 27, 1996)
  • K962233 — TWIST-OFF SCREW (October 3, 1996)
  • K962236 — SCARF THREAD-HEAD SCREW (September 20, 1996)
  • K960642 — NANCY NAIL (May 17, 1996)

Other clearances for product code LZN

  • K220838 — Artisan Bone Plug, Universal Cement Restrictor (May 20, 2022)
  • K061824 — TORNIER CEMENT RESTRICTOR (September 14, 2006)
  • K032685 — CEMSTOP CEMENT RESTRICTOR (November 26, 2003)
  • K023680 — BIOBUCK CEMENT RESTRICTOR (November 19, 2002)
  • K011943 — IMPRO VISE ABSORBABLE CEMENT FLOW RESTRICTOR (September 19, 2001)
  • K010840 — SYNPLUG (April 20, 2001)
  • K993841 — CEMSTOP CEMENT RESTRICTOR (May 4, 2000)
  • K000587 — SHUTTLE STOP (May 4, 2000)
  • K992462 — OSTEONICS UNIVERSAL DISTAL CEMENT PLUG (August 13, 1999)
  • K972411 — LINK CEMENT PLUG (August 29, 1997)