GIZA(R) VERTEBRAL BODY REPLACEMENT— 510(k) K112429

Name: FDA 510(k) clearance K112429
Creator: U.S. Food and Drug Administration
Published: 2012-01-26

Substantially Equivalent

Eden Spine, LLC

FDA 510(k) clearance K112429 for GIZA(R) VERTEBRAL BODY REPLACEMENT, Substantially Equivalent on 2012-01-26. Applicant: Eden Spine, LLC. Device class: 2.

Clearance details

Applicant: Eden Spine, LLC
Product code: Code MQP
Device class: Class 2
Regulation: 21 CFR 888.3060
Advisory panel: Orthopedic
Date received: 2011-08-23
Decision date: 2012-01-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Apple Valley, MN, US

Download summary PDF View on FDA.gov ↗

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K232790 — KONG®-TL VBR System and KONG® C VBR System2024-04-04

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K160982 — Sphynx2016-12-22

Adverse events under product code MQP

product code MQP

Injury: 372
Malfunction: 519
Total: 891

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K112429

K-number listed on FDA's recall record

Z-2072-2017 — GIZA Vertebral Body ReplacementClass II·Terminated·Eden Spine Europe SA·20170317

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K112429.

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