Home / 510(k) Clearances / K161114

510(k) K161114

HIGH V+ by Teknimed Sas — Product Code NDN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 12, 2017
Date Received
April 20, 2016
Clearance Type
Traditional
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 Sas

  • K242216 — GENTAFIX® (1, 3, 3MV) (December 18, 2024)
  • K230394 — EUROSCREW NG; EUROSCREW TCP NG (May 12, 2023)
  • K103816 — COHESION BONE CEMENT (February 4, 2011)
  • K103433 — F20 (January 3, 2011)
  • K090435 — VERTECEM (December 21, 2009)
  • 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)

Other clearances for product code NDN

  • K251896 — XeliteMed SuperM-Fix Spinal Bone Cement (January 28, 2026)
  • K250637 — VCFix Spinal System (May 30, 2025)
  • K243537 — XeliteMed VertehighFix High Viscosity Spinal Bone Cement System (April 11, 2025)
  • K241775 — XeliteMed VertehighFix High Viscosity Spinal Bone Cement (September 18, 2024)
  • K232842 — Balloon Inflation System (February 29, 2024)
  • K240084 — V-STRUT® Vertebral Implant (February 9, 2024)
  • 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)