510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
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K110046Substantially Equivalent

Athena Pedicle Screw System

Royal Oak Medical Devices, Bloomfield Hills MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K110046 is the FDA 510(k) clearance record for ATHENA PEDICLE SCREW SYSTEM, a class II device, cleared for Royal Oak Medical Devices on under FDA product code NKB (Thoracolumbosacral Pedicle Screw System). FDA's definition for product code NKB reads: "Intended to provide immobilization and stabilization of spinal segments in thoracic, lumbar, and sacral spine as an adjunct to fusion". FDA records list 2 510(k) clearances for Royal Oak Medical Devices, from to . As of , FDA records show no recalls naming K110046.

Clearance record

Decision date
Received
(335 days to decision)
Product code
NKB Thoracolumbosacral Pedicle Screw System
Regulation
21 CFR 888.3070
Device class
Class II
Review panel
Orthopedic
Applicant
Royal Oak Medical Devices 39533 Woodward Ave., Bloomfield Hills MI
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NKB

Trailing 12 months
33 clearances under product code NKB in the twelve months to October 2026, September 2026 the highest month at 7.
Show the numbers
Monthly 510(k) clearances under FDA product code NKB, trailing twelve months
MonthClearances
November 20251
December 20252
January 20263
February 20263
March 20260
April 20265
May 20264
June 20262
July 20264
August 20260
September 20267
October 20262