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XeliteMed VertehighFix High Viscosity Spinal Bone Cement System — Xelite Biomed , Ltd. (510(k) K243537)

XeliteMed VertehighFix High Viscosity Spinal Bone Cement System — Xelite Biomed , Ltd. (510(k) K243537) is one of 9,000 device clearances in the DeviceClear dataset. Key details — Device name: XeliteMed VertehighFix High Viscosity Spinal Bone Cement System; Applicant: Xelite Biomed , Ltd.; Clearance track: 510(k).

Device nameXeliteMed VertehighFix High Viscosity Spinal Bone Cement System
ApplicantXelite Biomed , Ltd.
Clearance track510(k)
Submission numberK243537
DecisionSubstantially Equivalent
Decision date2025-04-11
Date received2024-11-15
Product codeNDN
Device class2
Medical specialtyOrthopedic
Applicant locationTW
SourceopenFDA device

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