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510(k) K241775

XeliteMed VertehighFix High Viscosity Spinal Bone Cement by Xelite Biomed , Ltd. — Product Code NDN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 18, 2024
Date Received
June 20, 2024
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 Xelite Biomed , Ltd.

  • K251896 — XeliteMed SuperM-Fix Spinal Bone Cement (January 28, 2026)
  • K243537 — XeliteMed VertehighFix High Viscosity Spinal Bone Cement System (April 11, 2025)

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)
  • 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)
  • K211797 — TRACKER Plus Kyphoplasty System (October 28, 2021)