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510(k) K090435

VERTECEM by Teknimed, S.A. — Product Code NDN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 21, 2009
Date Received
February 19, 2009
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by Teknimed, S.A.

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  • K161114 — HIGH V+ (April 12, 2017)
  • K103816 — COHESION BONE CEMENT (February 4, 2011)
  • K103433 — F20 (January 3, 2011)
  • K083005 — NANGEL (March 4, 2009)
  • K080873 — OPACITY + BONE CEMENT (August 28, 2008)
  • K062102 — ODONCER (April 16, 2007)
  • K043593 — SPINE-FIX BIOMIMETIC BONE CEMENT (March 17, 2006)
  • K042911 — CEMENTEK LV (December 27, 2004)

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  • K241775 — XeliteMed VertehighFix High Viscosity Spinal Bone Cement (September 18, 2024)
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  • K231340 — Renova Spine Balloon Catheter (October 30, 2023)
  • K221697 — INJECTION PIN (KIP(02031-02061) (03031-03061)) (March 3, 2023)
  • K223294 — SpineJack® Expansion Kit (December 20, 2022)
  • K220131 — KYPHON VuE Bone Cement (April 18, 2022)