Home GUDID 00842078116197 AlignX
Primary DI 00842078116197
Brand AlignX
Company EXTREMITY MEDICAL, LLC
Model 136-00200
Device description Lateral Planer
Published 2026-10-29
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
Single use true Product Codes# Code, Name table Code Name LXH Orthopedic Manual Surgical Instrument
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class LXH Orthopedic Manual Surgical Instrument Orthopedic 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00842078116197 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00842078116197 00842078116197 842078116197 0842078116197
GMDN Terms# Term, Definition table Term Definition Bone file/rasp, reciprocating, single-use A surgical instrument with a surface(s) of coarse and/or fine grooves or teeth designed to be attached to a reciprocating power tool handpiece to scrape and smooth the surface of bone during a surgical procedure. It has grooves/teeth along all or part of the distal working end and is made of metal [e.g., stainless steel, titanium (Ti)]; it is not dedicated for use at a specific anatomy (e.g., sinus, ear). This is a single-use device.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 832720358 Device count 1 DM exempt false Premarket exempt true HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label false Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00840606197472 OMEGA XP SPINAL ELEMENTS, INC. LXH 2026-10-29 00842078100219 HammerFiX EXTREMITY MEDICAL, LLC LXH 2026-10-29 00842078100479 IO FiX EXTREMITY MEDICAL, LLC LXH 2026-10-29 00842078100486 XMCP EXTREMITY MEDICAL, LLC LXH 2026-10-29 00842078112410 Axis Beams EXTREMITY MEDICAL, LLC LXH 2026-10-29 00842078123584 KinematX Total EXTREMITY MEDICAL, LLC LXH 2026-10-29 00842078124178 Lapidus Joint Prep EXTREMITY MEDICAL, LLC LXH 2026-10-29 00842078124185 Lapidus Joint Prep EXTREMITY MEDICAL, LLC LXH 2026-10-29 00842078124215 Lapidus Joint Prep EXTREMITY MEDICAL, LLC LXH 2026-10-29 00842078129609 KinematX Total EXTREMITY MEDICAL, LLC LXH 2026-10-29 00842078129616 KinematX Total EXTREMITY MEDICAL, LLC LXH 2026-10-29 00842078129623 KinematX Total EXTREMITY MEDICAL, LLC LXH 2026-10-29 00842078129753 IO Freedom EXTREMITY MEDICAL, LLC LXH 2026-10-29 00842078129777 IO Freedom EXTREMITY MEDICAL, LLC LXH 2026-10-29 00842078129784 IO Freedom EXTREMITY MEDICAL, LLC LXH 2026-10-29 00842078129791 IO Freedom EXTREMITY MEDICAL, LLC LXH 2026-10-29 04250337122432 iLESSYS® Interlaminar Endoscopic Surgical System Joimax GmbH LXH 2026-10-29 07630699700689 Knee Instruments Medacta International SA LXH 2026-10-29 08800017276182 LOSPA Corentec Co., Ltd LXH 2026-10-29 08806373878039 LOSPA Corentec Co., Ltd LXH 2026-10-29 08806373889653 LOSPA Corentec Co., Ltd LXH 2026-10-29 08806373894190 LOSPA Corentec Co., Ltd LXH 2026-10-29 10850070500101 Core Wire, Removal Tool, Reusable CURVAFIX, INC. LXH 2026-10-29 10855068008935 Removal Tool Core Wire, Disposable CURVAFIX, INC. LXH 2026-10-29 10888857615779 K2M General Instruments VB Spine LLC LXH 2026-10-28 M739193990906 Non-Modular Convex Trial CAPTIVA SPINE, INC. LXH 2026-10-28 M739193996906 Non-Modular Lordotic Trial Assembly CAPTIVA SPINE, INC. LXH 2026-10-28 M739243999005 SG Implant Driver-S CAPTIVA SPINE, INC. LXH 2026-10-28 M739985202229 Marking Pin CAPTIVA SPINE, INC. LXH 2026-10-28 M739985203229 Marking Pin CAPTIVA SPINE, INC. LXH 2026-10-28