FDA.reportPublic FDA data

Artemis Proximal Femoral Nail System

Primary DI
18400659000120
Brand
Artemis Proximal Femoral Nail System
Company
Glw, Inc.
Model
T5-0170-000
Catalog number
T5-0170-000
Device description
ARTEMIS nail PF, Opening Reamer, Zimmer/Hall coupling
Published
2025-01-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
18400659000120PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1840065900012018400659000120

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implant reamerA surgical tool designed to over-drill a cylindrical orthopaedic implant (screw, pin, intrameduallry nail) to facilitate its removal by excising overgrown bone or other tissue. It is in the form of a hollow fluted metal shaft, with saw teeth at the cutting edge, available in a variety of sizes to match the different sizes of implant. This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
081102081
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
18435711006550CREED Edge Ortholucent ImplantsR5-1343-065SR5-1343-065S2026-01-28
18435711006574CREED Edge Ortholucent ImplantsR5-1320-070SR5-1320-070S2026-01-28
18435711006604CREED Edge Ortholucent ImplantsR5-3030-100SR5-3030-100S2026-01-28
18435711006642CREED Edge Ortholucent ImplantsR5-1020-055SR5-1020-055S2026-01-28
18435711006666CREED Edge Ortholucent ImplantsR5-2031-070SR5-2031-070S2026-01-28
18435711006710CREED Edge Ortholucent ImplantsR5-2222-075SR5-2222-075S2026-01-28
18435711007762CREED Edge Ortholucent ImplantsF9-1974-034SF9-1974-034S2026-01-28
18435711007779CREED Edge Ortholucent ImplantsF9-1974-036SF9-1974-036S2026-01-28
18435711007786CREED Edge Ortholucent ImplantsF9-1974-038SF9-1974-038S2026-01-28
18435711007793CREED Edge Ortholucent ImplantsF9-1974-040SF9-1974-040S2026-01-28
18435711007809CREED Edge Ortholucent ImplantsF9-1974-042SF9-1974-042S2026-01-28
18435711007816CREED Edge Ortholucent ImplantsF9-1974-044SF9-1974-044S2026-01-28
18435711007823CREED Edge Ortholucent ImplantsF9-1974-046SF9-1974-046S2026-01-28
18435711007830CREED Edge Ortholucent ImplantsF9-1974-048SF9-1974-048S2026-01-28
18435711007847CREED Edge Ortholucent ImplantsF9-1974-050SF9-1974-050S2026-01-28
18435711007854CREED Edge Ortholucent ImplantsF9-1974-055SF9-1974-055S2026-01-28
18435711007861CREED Edge Ortholucent ImplantsF9-1974-060SF9-1974-060S2026-01-28
18435711007878CREED Edge Ortholucent ImplantsF9-1974-065SF9-1974-065S2026-01-28
18435711007885CREED Edge Ortholucent ImplantsF9-1974-070SF9-1974-070S2026-01-28
18435711007892CREED Edge Ortholucent ImplantsF9-1974-075SF9-1974-075S2026-01-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000880118MSB Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.LXH2026-10-23
00842528130056OSTEOMEDOSTEOMED LLCLXH2026-10-23
00888867550391Arthrex®ARTHREX, INC.LXH2026-10-23
00888867550407Arthrex®ARTHREX, INC.LXH2026-10-23
00888867550414Arthrex®ARTHREX, INC.LXH2026-10-23
00888867550421Arthrex®ARTHREX, INC.LXH2026-10-23
04251631412144BEE PLIFNGMedical GmbHLXH2026-10-23
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M739153998800Cross Connector Counter TorqueCAPTIVA SPINE, INC.LXH2026-10-23
M739243501000Blade DilatorCAPTIVA SPINE, INC.LXH2026-10-23
M739243502000Parallel GuideCAPTIVA SPINE, INC.LXH2026-10-23
M739243503000In-Line HandleCAPTIVA SPINE, INC.LXH2026-10-23
M739243504000Tissue DilatorCAPTIVA SPINE, INC.LXH2026-10-23
M739243505000Tissue ProtectorCAPTIVA SPINE, INC.LXH2026-10-23
M739243506000Adjustable Parallel GuideCAPTIVA SPINE, INC.LXH2026-10-23
M739243507000Impaction SleeveCAPTIVA SPINE, INC.LXH2026-10-23
M739243508000Self-Feeding DrillCAPTIVA SPINE, INC.LXH2026-10-23
M739243509000Implant Filling TubeCAPTIVA SPINE, INC.LXH2026-10-23
M739243511000Plunger RodCAPTIVA SPINE, INC.LXH2026-10-23
M739243512000Cannulated Drill, 7mmCAPTIVA SPINE, INC.LXH2026-10-23
M7399830151066mm Cannulated DrillCAPTIVA SPINE, INC.LXH2026-10-23
M7399830151077mm Cannulated DrillCAPTIVA SPINE, INC.LXH2026-10-23
M7399830151088mm Cannulated DrillCAPTIVA SPINE, INC.LXH2026-10-23
M7399830151099mm Cannulated DrillCAPTIVA SPINE, INC.LXH2026-10-23
M73998301511010mm Cannulated DrillCAPTIVA SPINE, INC.LXH2026-10-23
M73998301511111mm Cannulated DrillCAPTIVA SPINE, INC.LXH2026-10-23
M73998301511212mm Cannulated DrillCAPTIVA SPINE, INC.LXH2026-10-23
M739983101200Coupling - Square ConnectCAPTIVA SPINE, INC.LXH2026-10-23
M739983240300Impaction T-HandleCAPTIVA SPINE, INC.LXH2026-10-23
M739985202530Marking PinCAPTIVA SPINE, INC.LXH2026-10-23