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510(k) K050085

OSTEOPAL V by Heraeus Kulzer,GmbH — Product Code LOD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 14, 2005
Date Received
January 13, 2005
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bone Cement
Device Class
Class II
Regulation Number
888.3027
Review Panel
OR
Submission Type

Other clearances by Heraeus Kulzer,GmbH

  • K130647 — XANTASIL DYNAMIX FAST SET CARTRIDGE -2 X 380ML; XANTASIL FAST SET CARTRIDGE -6 X (May 17, 2013)
  • K123278 — IBOND SELF ETCH BOTTLE ASSORTMENT, IBOND SELF ETCH BOTTLE VALUE PACK, IBOND SELF (December 7, 2012)
  • K120914 — FLEXITIME FAST & SCAN LIGHT FLOW (July 25, 2012)
  • K113574 — FLEXITIME MONOPHASE PRO SCAN (July 13, 2012)
  • K112501 — VENUS PEARL PLT REFILL A1 (December 14, 2011)
  • K111832 — PALADON ULTRA POWDER (PINK), PALADON ULTRA LIQUID (September 29, 2011)
  • K110037 — PALAXPRESS ULTRA POWDER (PINK); PALAXPRESS ULTRA LIQUID (April 29, 2011)
  • K102770 — FLEXTIME FAST & SCAN PUTTY, FLEXTIME FAST & SCAN LIGHT FLOW, FLEXTIME FAST & SCA (December 21, 2010)
  • K101617 — FLEXITIME XTREME 2 HEAVY TRAY CARTRIDGE REFILL, FEXITIME XTREME 2 LIGHT TRAY CAR (September 7, 2010)
  • K093575 — GLUMA DESENSITIZER POWER GEL (March 5, 2010)

Other clearances for product code LOD

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  • K241674 — OSTEOPAL® V (December 5, 2024)
  • K231556 — SPECTRUM® GV Bone Cement (December 20, 2023)
  • K211163 — Bone Cement Genta, Bone Cement HV, Bone Cement LV (January 9, 2023)
  • K212729 — Bone Cement-Normal Viscosity (May 31, 2022)
  • K211869 — OGM 1 Polymethylmethacrylate (PMMA) bone cement, OGM 1A Polymethylmethacrylate ( (May 19, 2022)
  • K213812 — PALACOS MV pro (February 2, 2022)
  • K210607 — PALACOS R pro, PALACOS R+G pro, PALACOS MV+G pro (July 9, 2021)
  • K202458 — BonOs Inject, Pedicle screw kits, Cement pusher (May 18, 2021)
  • K210120 — BonOs HV, BonOs MV, BonOs LV (March 19, 2021)