510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K100805Substantially Equivalent

Gallery Laminoplasty Fixation System

Biomet Spine (Aka Ebi, LLC), Parsippany NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K100805 is the FDA 510(k) clearance record for GALLERY LAMINOPLASTY FIXATION SYSTEM, a class II device, cleared for Biomet Spine (Aka Ebi, LLC) on under FDA product code NQW (Orthosis, Spine, Plate, Laminoplasty, Metal). FDA's definition for product code NQW reads: "This device is a plate that is attached to the lamina after a laminoplasty or laminectomy procedure". FDA records list 13 510(k) clearances for Biomet Spine (Aka Ebi, LLC), from to . As of , FDA records show no recalls naming K100805.

Clearance record

Decision date
Received
(120 days to decision)
Product code
NQW Orthosis, Spine, Plate, Laminoplasty, Metal
Regulation
21 CFR 888.3050
Device class
Class II
Review panel
Orthopedic
Applicant
Biomet Spine (Aka Ebi, LLC) 100 Interpace Pkwy., Parsippany NJ
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NQW

Trailing 12 months
1 clearance under product code NQW in the twelve months to October 2026, May 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code NQW, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20261
June 20260
July 20260
August 20260
September 20260
October 20260