510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K980852Substantially Equivalent

Gii Spinal Fixation System

Karen E. Warden, M.E.B.E., Cleveland OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K980852 is the FDA 510(k) clearance record for GII SPINAL FIXATION SYSTEM, a class II device, cleared for Karen E. Warden, M.E.B.E. on under FDA product code MNH (Orthosis, Spondylolisthesis Spinal Fixation). FDA records list one 510(k) clearance for Karen E. Warden, M.E.B.E. As of , FDA records show no recalls naming K980852.

Clearance record

Decision date
Received
(57 days to decision)
Product code
MNH Orthosis, Spondylolisthesis Spinal Fixation
Regulation
21 CFR 888.3070
Device class
Class II
Review panel
Orthopedic
Applicant
Karen E. Warden, M.E.B.E. 2249 Elm St., Suite 501, Cleveland OH
510(k) summary
Summary
Third party review
No

Clearances, product code MNH

Trailing 12 months

FDA records hold no clearances under product code MNH in the trailing twelve months.

FDA records show no clearances under product code MNH in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code MNH, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260