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510(k) K191709

V-STRUT Vertebral Implant by Hyprevention Sas — Product Code NDN

K191709 is an FDA 510(k) premarket notification submitted by Hyprevention Sas for the device "V-STRUT Vertebral Implant". The FDA issued a decision of Substantially Equivalent on March 5, 2020. The device falls under product code NDN (Cement, Bone, Vertebroplasty), a Class II device regulated under 21 CFR 888.3027. Hyprevention Sas has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 5, 2020
Date Received
June 26, 2019
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 Hyprevention Sas

  • K240084 — V-STRUT® Vertebral Implant (February 9, 2024)

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)

FDA data resources