Cleared Traditional

RELIANCE BUTTRESS WASHER SYSTEM

K073349 · Reliance Medical Systems, LLC · Orthopedic
Feb 2008
Decision
76d
Days
Class 2
Risk

About This 510(k) Submission

K073349 is an FDA 510(k) clearance for the RELIANCE BUTTRESS WASHER SYSTEM, a Appliance, Fixation, Spinal Intervertebral Body (Class II — Special Controls, product code KWQ), submitted by Reliance Medical Systems, LLC (Sandy, US). The FDA issued a Cleared decision on February 13, 2008, 76 days after receiving the submission on November 29, 2007. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3060.

Submission Details

510(k) Number K073349 FDA.gov
FDA Decision Cleared SESE
Date Received November 29, 2007
Decision Date February 13, 2008
Days to Decision 76 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code KWQ — Appliance, Fixation, Spinal Intervertebral Body
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3060

Similar Devices — KWQ Appliance, Fixation, Spinal Intervertebral Body

All 661
ANTERIS Thoracolumbar Plate System
K260015 · SpineCraft · Mar 2026
PathLoc Lumbar Plate System
K251940 · L & K Biomed Co., Ltd. · Mar 2026
Aster
K254182 · Osteonic Co., Ltd. · Feb 2026
Lumbar Spine Truss System - Plating Solution (LSTS-PS)
K253201 · 4Web, Inc. · Feb 2026
aprevo? cervical plating system
K252611 · Carlsmed, Inc. · Dec 2025
Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)
K251965 · Alphatec Spine, Inc. · Aug 2025