FDA.reportPublic FDA data

Glenojet Angled Guide

Primary DI
M528G50015000
Brand
Glenojet Angled Guide
Company
ARTHROSURFACE INCORPORATED
Model
G500-1500
Published
2026-03-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M528G50015000PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Joint prosthesis implantation kit, single-useA collection of surgical instruments intended to be used for cutting and forming bone to enable the implantation of a joint prosthesis. The instruments include various metallic and/or plastic disposable devices (e.g., retractors, rods, clamps, drills, pins, saws, guides, cutting blocks, trial prosthesis) that are specific to the joint of application (e.g., hip, knee, shoulder, ankle, or elbow); the implant(s) is not included. This is a single-use device.

Regulatory Flags#

DUNS number
144666109
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M5288RB42310A0RevoMotion 8RB4-2310-A2026-05-21
M5288RG032ECA0RevoMotion 8RG0-32EC-A2026-05-21
M5288RG03600A0RevoMotion 8RG0-3600-A2026-05-21
M5288RG036ECA0RevoMotion 8RG0-36EC-A2026-05-21
M5288RG04000A0RevoMotion 8RG0-4000-A2026-05-21
M5288RG040ECA0RevoMotion 8RG0-40EC-A2026-05-21
M5288RG23200A0RevoMotion 8RG2-3200-A2026-05-21
M5288RG232ECA0RevoMotion 8RG2-32EC-A2026-05-21
M5288RG23600A0RevoMotion 8RG2-3600-A2026-05-21
M5288RG236ECA0RevoMotion 8RG2-36EC-A2026-05-21
M5288RG24000A0RevoMotion 8RG2-4000-A2026-05-21
M5288RG240ECA0RevoMotion 8RG2-40EC-A2026-05-21
M5288RG43200A0RevoMotion 3RG4-3200-A2026-05-21
M5288RG43600A0RevoMotion 8RG4-3600-A2026-05-21
M5288RG44000A0RevoMotion 8RG4-4000-A2026-05-21
M5288RM20600A0RevoMotion 8RM2-0600-A2026-05-21
M5288RM20800A0RevoMotion 8RM2-0800-A2026-05-21
M5288RM21000A0RevoMotion 8RM2-1000-A2026-05-21
M5288RM21200A0RevoMotion 8RM2-1200-A2026-05-21
M5288RM21400A0RevoMotion 8RM2-1400-A2026-05-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00199150083473Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.LXH2026-08-03
B382SD480033220Surgical DirectSurgical Direct, Inc.LXH2026-08-03
B382SD480090Surgical DirectSurgical Direct, Inc.LXH2026-08-03
B382SD4834330Surgical DirectSurgical Direct, Inc.LXH2026-08-03
B382SD493760Surgical DirectSurgical Direct, Inc.LXH2026-08-03
00190776407391MillenniumAvalign Technologies, Inc.LXH2026-07-31
00840606191579Overwatch PCFSPINAL ELEMENTS, INC.LXH2026-07-31
00840606191630Overwatch PCFSPINAL ELEMENTS, INC.LXH2026-07-31
00840606191647Overwatch PCFSPINAL ELEMENTS, INC.LXH2026-07-31
00840606191678Overwatch PCFSPINAL ELEMENTS, INC.LXH2026-07-31
00840606191685Overwatch PCFSPINAL ELEMENTS, INC.LXH2026-07-31
00840606191692Overwatch PCFSPINAL ELEMENTS, INC.LXH2026-07-31
00840606191708Overwatch PCFSPINAL ELEMENTS, INC.LXH2026-07-31
00840606191722Overwatch PCFSPINAL ELEMENTS, INC.LXH2026-07-31
00840606191739Overwatch PCFSPINAL ELEMENTS, INC.LXH2026-07-31
00840606191777Overwatch PCFSPINAL ELEMENTS, INC.LXH2026-07-31
00840606191920Overwatch PCFSPINAL ELEMENTS, INC.LXH2026-07-31
00840606191937Overwatch PCFSPINAL ELEMENTS, INC.LXH2026-07-31
00840606191968Overwatch PCFSPINAL ELEMENTS, INC.LXH2026-07-31
00840606191999Overwatch PCFSPINAL ELEMENTS, INC.LXH2026-07-31
00888867532236Arthrex®ARTHREX, INC.LXH2026-07-31
00888867532243Arthrex®ARTHREX, INC.LXH2026-07-31
00888867532250Arthrex®ARTHREX, INC.LXH2026-07-31
00888867532267Arthrex®ARTHREX, INC.LXH2026-07-31
00888867532274Arthrex®ARTHREX, INC.LXH2026-07-31
00888867544819Arthrex®ARTHREX, INC.LXH2026-07-31
00888867544826Arthrex®ARTHREX, INC.LXH2026-07-31
00888867544833Arthrex®ARTHREX, INC.LXH2026-07-31
00888867544840Arthrex®ARTHREX, INC.LXH2026-07-31
00888867544857Arthrex®ARTHREX, INC.LXH2026-07-31