Home GUDID 00822409133901 N/A
Primary DI 00822409133901
Brand N/A
Company Ortho Development Corporation
Model C-1862-20
Device description CR Insert Trial with Handle Mating Hole Size 7 20mm
Published 2026-05-16
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx 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 00822409133901 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 00822409133901 00822409133901 822409133901 0822409133901
GMDN Terms# Term, Definition table Term Definition Knee tibia prosthesis trial, reusable A copy of a final tibia prosthesis designed to be used during unicompartmental knee replacement surgery or total knee arthroplasty (TKA) to determine the correct alignment, size, and fit of the final prosthesis. It is one of a set, or a set, of graduated sizes, and may be used in conjunction with a knee femur trial prosthesis and a patella trial prosthesis. It is typically made of metal or polymer material and includes tibial base plate trials, tibial spacer trials, tibial insert trials, tibial stem trials, tibial wedge/augment trials, and guide pin trials. This is a reusable device.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 876542390 Device count 1 Premarket exempt true Lot or batch true Manufacturing date on label true 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 M9432002220000 Minuteman Spinal Simplicity, LLC LXH 2026-09-04 07613327697209 PANGEA Stryker GmbH LXH 2026-08-27 00840606185950 ALIF SPINAL ELEMENTS, INC. LXH 2026-08-26 00840606185967 ALIF SPINAL ELEMENTS, INC. LXH 2026-08-26 00840606185974 ALIF SPINAL ELEMENTS, INC. LXH 2026-08-26 00840606185981 ALIF SPINAL ELEMENTS, INC. LXH 2026-08-26 00840606185998 ALIF SPINAL ELEMENTS, INC. LXH 2026-08-26 00840606186001 ALIF SPINAL ELEMENTS, INC. LXH 2026-08-26 00840606186018 ALIF SPINAL ELEMENTS, INC. LXH 2026-08-26 00840606186025 ALIF SPINAL ELEMENTS, INC. LXH 2026-08-26 00840606186032 ALIF SPINAL ELEMENTS, INC. LXH 2026-08-26 00840606186049 ALIF SPINAL ELEMENTS, INC. LXH 2026-08-26 00840606186056 ALIF SPINAL ELEMENTS, INC. LXH 2026-08-26 00840606186063 ALIF SPINAL ELEMENTS, INC. LXH 2026-08-26 00840606186070 ALIF SPINAL ELEMENTS, INC. LXH 2026-08-26 00840606186087 ALIF SPINAL ELEMENTS, INC. LXH 2026-08-26 00840606186094 ALIF SPINAL ELEMENTS, INC. LXH 2026-08-26 00840606186100 ALIF SPINAL ELEMENTS, INC. LXH 2026-08-26 00840606186117 ALIF SPINAL ELEMENTS, INC. LXH 2026-08-26 00840606186124 ALIF SPINAL ELEMENTS, INC. LXH 2026-08-26 00840606186131 ALIF SPINAL ELEMENTS, INC. LXH 2026-08-26 00840606186148 ALIF SPINAL ELEMENTS, INC. LXH 2026-08-26 00840606186155 ALIF SPINAL ELEMENTS, INC. LXH 2026-08-26 00840606186162 ALIF SPINAL ELEMENTS, INC. LXH 2026-08-26 00840606186179 ALIF SPINAL ELEMENTS, INC. LXH 2026-08-26 00840606186186 ALIF SPINAL ELEMENTS, INC. LXH 2026-08-26 00840606186193 ALIF SPINAL ELEMENTS, INC. LXH 2026-08-26 00840606186209 ALIF SPINAL ELEMENTS, INC. LXH 2026-08-26 00840606186247 ALIF SPINAL ELEMENTS, INC. LXH 2026-08-26 00840606186254 ALIF SPINAL ELEMENTS, INC. LXH 2026-08-26