510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K201079Substantially Equivalent

Aurora® Anterior Lumbar Plate Sytstem

Prism Surgical Design Pty, Ltd., Milton, AU / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K201079 is the FDA 510(k) clearance record for Aurora® Anterior Lumbar Plate Sytstem, a class II device, cleared for Prism Surgical Design Pty , Ltd. on under FDA product code KWQ (Appliance, Fixation, Spinal Intervertebral Body). FDA records list one 510(k) clearance for Prism Surgical Design Pty , Ltd. As of , FDA records show no recalls naming K201079.

Clearance record

Decision date
Received
(105 days to decision)
Product code
KWQ Appliance, Fixation, Spinal Intervertebral Body
Regulation
21 CFR 888.3060
Device class
Class II
Review panel
Orthopedic
Applicant
Prism Surgical Design Pty , Ltd. 15/43 Lang Parade, Milton, AU
510(k) summary
Summary PDF
Third party review
No

Clearances, product code KWQ

Trailing 12 months
11 clearances under product code KWQ in the twelve months to October 2026, March 2026 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code KWQ, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20262
March 20263
April 20261
May 20262
June 20260
July 20261
August 20260
September 20261
October 20260