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510(k) K972411

LINK CEMENT PLUG by Turnkey Intergration USA, Inc. — Product Code LZN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 29, 1997
Date Received
June 26, 1997
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 Turnkey Intergration USA, Inc.

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  • K990523 — B2C, ESPACE REVISION CUP SYSTEM (April 30, 1999)
  • K990307 — OMNI-FIX, NAIL SYSTEM (April 1, 1999)
  • K970284 — ARTOS, DIPLOS SYSTEM (April 21, 1997)
  • K970084 — LINK CERCLAGE WIRE SYSTEM (March 13, 1997)
  • K953653 — LUBINUS SP II HIP SYSTEM (November 6, 1995)
  • K943986 — LINK ENDO MODEL REVISION CUP (July 5, 1995)
  • K951355 — LINK SADDLE PROTHESIS (May 25, 1995)
  • K950397 — SYSTEM 22 VALVE (April 14, 1995)
  • K940297 — UNIVERSAL WRIST (February 6, 1995)

Other clearances for product code LZN

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  • 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)
  • K000587 — SHUTTLE STOP (May 4, 2000)
  • K993841 — CEMSTOP CEMENT RESTRICTOR (May 4, 2000)
  • K992462 — OSTEONICS UNIVERSAL DISTAL CEMENT PLUG (August 13, 1999)
  • K970779 — OSTEONICS TIBIAL TRAY SCREW HOLE PLUGS (May 9, 1997)