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510(k) K943727

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

K943727 is an FDA 510(k) premarket notification submitted by Landos, Inc. for the device "BIOSTOP G BONE CEMENT RESTRICTOR". The FDA issued a decision of Substantially Equivalent on May 11, 1995. The device falls under product code LZN (Cement Obturator), a Class II device regulated under 21 CFR 878.3300. Landos, Inc. has at least 10 other 510(k) clearances on record.

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.

  • K964226 — MEMORY STAPLE (20 SIZES AVAILABLE) (August 5, 1997)
  • K971069 — TWIST-OFF (TM) SCREW (July 9, 1997)
  • K971070 — SCARF THREAD-HEAD (TM) HEAD SCREW (July 9, 1997)
  • K971068 — 34MM SCARF THREAD-HEAD(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)

FDA data resources