Vivorte Trabexus EB— 510(k) K143547

Substantially Equivalent

Vivorte, Inc.

FDA 510(k) clearance K143547 for Vivorte Trabexus EB, Substantially Equivalent on 2015-01-14. Applicant: Vivorte, Inc.. Device class: 2.

Clearance details

Applicant: Vivorte, Inc.
Product code: Code MBP
Device class: Class 2
Regulation: 21 CFR 888.3045
Advisory panel: Orthopedic
Date received: 2014-12-15
Decision date: 2015-01-14
Decision: Substantially Equivalent
Clearance type: Special
Location: Louisville, KY, US

Download summary PDF View on FDA.gov ↗

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More clearances from Vivorte, Inc.

K143549 — Vivorte Trabexus2015-01-14
K131133 — VIVORTE BVF LITE2013-08-12

Recalls naming K143547

K-number listed on FDA's recall record

Z-2024-2021 — Vivorte Trabexus EB 10 cc Bone Void Filler -Fill bone and/or defect in skeletal system Model Number: 130703-10Class II·Terminated·Vivorte, Inc.·20180909

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K143547.

Data sourced from openFDA. This site is unofficial and independent of the FDA.