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510(k) K250637

VCFix Spinal System by Amber Implants — Product Code NDN

K250637 is an FDA 510(k) premarket notification submitted by Amber Implants for the device "VCFix Spinal System". The FDA issued a decision of Substantially Equivalent on May 30, 2025. The device falls under product code NDN (Cement, Bone, Vertebroplasty), a Class II device regulated under 21 CFR 888.3027.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 30, 2025
Date Received
March 3, 2025
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 for product code NDN

  • K251896 — XeliteMed SuperM-Fix Spinal Bone Cement (January 28, 2026)
  • 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)
  • K211797 — TRACKER Plus Kyphoplasty System (October 28, 2021)

FDA data resources