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NDN — Cement, Bone, Vertebroplasty Class II

FDA Device Classification

Classification Details

Product Code
NDN
Device Class
Class II
Regulation Number
888.3027
Submission Type
Review Panel
OR
Medical Specialty
Orthopedic
Implant
Yes

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K251896xelite biomedXeliteMed SuperM-Fix Spinal Bone CementJanuary 28, 2026
K250637amber implantsVCFix Spinal SystemMay 30, 2025
K243537xelite biomedXeliteMed VertehighFix High Viscosity Spinal Bone Cement SystemApril 11, 2025
K241775xelite biomedXeliteMed VertehighFix High Viscosity Spinal Bone CementSeptember 18, 2024
K232842ningbo hicren biotechnology coBalloon Inflation SystemFebruary 29, 2024
K240084hypreventionV-STRUT® Vertebral ImplantFebruary 9, 2024
K231340biopsybellRenova Spine Balloon CatheterOctober 30, 2023
K221697slk orthoINJECTION PIN (KIP(02031-02061) (03031-03061))March 3, 2023
K223294stryker instrumentsSpineJack® Expansion KitDecember 20, 2022
K220131tecresKYPHON VuE Bone CementApril 18, 2022
K211797gs medical coTRACKER Plus Kyphoplasty SystemOctober 28, 2021
K211238stryker instrumentsSpineJack Expansion Kit, Vertaplex Radiopaque Bone Cement, Vertaplex HV RadiopaqJune 25, 2021
K202393stryker corporationSpineJack Expansion KitOctober 20, 2020
K201831depuy spineCONFIDENCE Spinal Cement SystemAugust 31, 2020
K192449joline gmbh and co. kgJoline Kyphoplasty System AllevoMay 27, 2020
K191709hypreventionV-STRUT Vertebral ImplantMarch 5, 2020
K192335gs medical coTRACKER Kyphoplasty SystemDecember 4, 2019
K192403bonwrxVK100 Percutaneous Vertebral Augmentation SystemNovember 8, 2019
K181262veximSpineJack Expansion KitAugust 30, 2018
K172871hanchang coSpineKure Kyphoplasty SystemMay 29, 2018