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510(k) K010840

SYNPLUG by Isotis NV — Product Code LZN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 20, 2001
Date Received
March 21, 2001
Clearance Type
Special
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 Isotis NV

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  • K031813 — OSSATURA DENTAL (August 20, 2004)
  • K041344 — OPEN BORE SYRINGE (July 16, 2004)
  • K030131 — OSSATURA BCP BONE VOID FILLER (May 20, 2003)
  • K000587 — SHUTTLE STOP (May 4, 2000)

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)
  • 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)