Cleared Traditional

STRYKER ARIA PNEUMATIC SYSTEM

K061725 · Stryker Instruments · Neurology
Oct 2006
Decision
129d
Days
Class 2
Risk

About This 510(k) Submission

K061725 is an FDA 510(k) clearance for the STRYKER ARIA PNEUMATIC SYSTEM, a Motor, Drill, Pneumatic (Class II — Special Controls, product code HBB), submitted by Stryker Instruments (Kalamazoo, US). The FDA issued a Cleared decision on October 26, 2006, 129 days after receiving the submission on June 19, 2006. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4370.

Submission Details

510(k) Number K061725 FDA.gov
FDA Decision Cleared SESE
Date Received June 19, 2006
Decision Date October 26, 2006
Days to Decision 129 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code HBB — Motor, Drill, Pneumatic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.4370

Similar Devices — HBB Motor, Drill, Pneumatic

All 26
Velocity Alpha MR High Speed Surgical Drill System
K253772 · Adeor Medical AG · Mar 2026
ELAN 4 Air Motor System
K172907 · Aesculap, Inc. · Nov 2018
Medtronic Legend Pneumatic; MR7 Pneumatic; Triton Pneumatic Drill System incorporating various Pneumatic Handpieces; Attachments; Surgical Dissecting Tools; and System Accessories
K163182 · Medtronic Powered Surgical Solutions · Mar 2017
Stryker Maestro Air Motors
K150801 · Stryker Corporation · May 2015
LEGEND POWER ADAPTER MODEL: 6475000
K101168 · Medtronic Sofamor Danek · Aug 2010
SYNTHES AIR PEN DRIVE (APD) SYSTEM
K093361 · Synthes (Usa) · Apr 2010

More from Stryker Instruments

View all
RPS Primary TKA Software; RPS Console; RPS Saw One; RPS Cable; RPS Saw Oscillating Tip Cartridge; RPS Console Cart Attachment; Ball Tip Pointer
K251971 · OLO · Sep 2025
PhotonBlade 3; PhotonBlade 3 Smoke Evacuation
K250483 · GEI · Sep 2025
OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Single Kit); OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Dual Kit)
K250213 · GXI · May 2025
OptaBlate Radiofrequency (RF) Generator System
K250327 · GEI · Apr 2025
Sonopet iQ Ultrasonic Aspirator System (5500-050-000)
K243930 · LFL · Mar 2025