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510(k) K010840

SYNPLUG by Isotis NV — Product Code LZN

K010840 is an FDA 510(k) premarket notification submitted by Isotis NV for the device "SYNPLUG". The FDA issued a decision of Substantially Equivalent on April 20, 2001. The device falls under product code LZN (Cement Obturator), a Class II device regulated under 21 CFR 878.3300. Isotis NV has at least 7 other 510(k) clearances on record.

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

  • K061880 — ACCELI DBM FAMILY PRODUCTS, 0.5CC, 1CC, 2.5CC, 5CC, 10CC, 15CC, 30CC (August 15, 2007)
  • K060332 — ORTHOBLAST II DBM DEMINERALIZED BONE MATRIX PASTE AND PUTTY (March 29, 2006)
  • K060306 — ACCELL CONNEXUS DEMINERALIZED BONE MATRIX PUTTY (March 27, 2006)
  • 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)
  • 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)
  • K970779 — OSTEONICS TIBIAL TRAY SCREW HOLE PLUGS (May 9, 1997)

FDA data resources