510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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K112429Substantially Equivalent

Giza(r) Vertebral Body Replacement

Eden Spine, LLC, Apple Valley MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K112429 is the FDA 510(k) clearance record for GIZA(R) VERTEBRAL BODY REPLACEMENT, a class II device, cleared for Eden Spine, LLC on under FDA product code MQP (Spinal Vertebral Body Replacement Device). FDA records list 2 510(k) clearances for Eden Spine, LLC, from to . As of , FDA records show one recall naming K112429.

Clearance record

Decision date
Received
(156 days to decision)
Product code
MQP Spinal Vertebral Body Replacement Device
Regulation
21 CFR 888.3060
Device class
Class II
Review panel
Orthopedic
Applicant
Eden Spine, LLC 13540 Guild Ave., Apple Valley MN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MQP

Trailing 12 months
3 clearances under product code MQP in the twelve months to October 2026, July 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code MQP, trailing twelve months
MonthClearances
November 20250
December 20250
January 20261
February 20260
March 20260
April 20260
May 20260
June 20260
July 20262
August 20260
September 20260
October 20260