FDA.reportPublic FDA data

Artemis Proximal Femoral Nail System

Primary DI
18400659001813
Brand
Artemis Proximal Femoral Nail System
Company
Glw, Inc.
Model
T5-0540-000
Catalog number
T5-0540-000
Device description
Artemis Proximal Femoral Nail System, K-Wire, Drill Tip, ø3.5mm
Published
2025-01-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
18400659001813PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1840065900181318400659001813

GMDN Terms#

Term, Definition table
TermDefinition
Manual wire driverA hand-held manual surgical instrument (drill-like) designed to drive orthopaedic bone wires, e.g., Steinmann pins, Kirschner wires or K-Wires (thin needle-like pins of different thickness that are pointed for self-drilling) into fractured/deformed bones for their restoration. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
081102081
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Expiration date on label
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
00196449010196Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00196449010288Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00196449035243Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00196449035250Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00196449035267Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00196449035281Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00196449035298Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00196449035304Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00196449035311Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00196449035328Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00196449035335Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00196449035366Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00196449035380Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00196449035397Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00196449035441Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00196449035465Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00196449035472Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00810094692698Modular Frog EyesTOTAL JOINT ORTHOPEDICS, INC.LXH2026-06-09
00810094692704Distal Femoral Cut Block ConnectorTOTAL JOINT ORTHOPEDICS, INC.LXH2026-06-09
00810094692933Magnet Spacer, 5mmTOTAL JOINT ORTHOPEDICS, INC.LXH2026-06-09
04052536123728mamboUlrich GmbH & Co. KGLXH2026-06-09
08809945870578BENCOXCorentec Co., LtdLXH2026-06-09
04052536085668neon3Ulrich GmbH & Co. KGLXH2026-06-08
04052536162048neon3Ulrich GmbH & Co. KGLXH2026-06-08
04052536162079neon3Ulrich GmbH & Co. KGLXH2026-06-08
00198506091445ELMED INCORPORATEDELMED INCORPORATEDLXH2026-06-05
00199150076161Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.LXH2026-06-05
00840311263882Streamline OCTXtant Medical Holdings, Inc.LXH2026-06-04
00198506091179ELMED INCORPORATEDELMED INCORPORATEDLXH2026-06-03
08698940967426SayanSAYAN TIBBI ALETLER PAZARLAMA SANAYI VE TICARET LIMITED SIRKETILXH2026-06-03