FDA.reportPublic FDA data

Artemis Proximal Femoral Nail System

Primary DI
18400659000472
Brand
Artemis Proximal Femoral Nail System
Company
Glw, Inc.
Model
T6-0200-080S
Catalog number
T6-0200-080S
Device description
ARTEMIS nail PF, Lag Screw, ø11 x 80
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
HWCScrew, Fixation, Bone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWCScrew, Fixation, BoneOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K201379000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K201379000Artemis Proximal Femoral Nail SystemGlw, Inc.2021-02-19HSB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
18400659000472PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1840065900047218400659000472

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone screw (non-sliding)A small, threaded, non-bioabsorbable, implantable rod intended for internal orthopaedic fixation by being screwed into a limb bone, rib, the sternum and/or pelvis to hold a plate, nail, rod or prosthesis to the bone, or to provide direct interfragmentary stabilization of a fractured bone; it is not intended to be introduced through the sleeve of a femoral neck fixation plate/sleeve, not used in dentistry/orthodontics, craniofacial or spinal bones, and not dedicated to intramedullary fixation/arthrodesis. It is typically of cortical or cancellous design and has a drive (e.g., slot, cross, star, polygonal) at its proximal end for introduction with a screwdriver.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
081102081
Device count
1
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
00688346003918Fine TTOLaboratoires Bodycad IncHWC2026-08-03
00688346005356Fine Osteotomy System - Femoral plateLaboratoires Bodycad IncHWC2026-08-03
00688346005387Fine Osteotomy System - Femoral plateLaboratoires Bodycad IncHWC2026-08-03
00688346005523Fine Osteotomy System - Tibial plateLaboratoires Bodycad IncHWC2026-08-03
00688346005554Fine Osteotomy System - Tibial plateLaboratoires Bodycad IncHWC2026-08-03
07899258606637Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-07-30
07899258606644Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-07-30
07899258606651Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-07-30
07899258606668Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-07-30
07899258606675Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-07-30
07899258606682Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-07-30
07899258606699Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-07-30
07899258606705Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-07-30
07899258606712Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-07-30
07899258606729Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-07-30
07899258606736Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-07-30
07899258606743Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-07-30
07899258606750Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-07-30
07899258606767Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-07-30
07899258606774Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-07-30
07899258606781Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-07-30
07899258606798Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-07-30
07899258606804Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-07-30
07899258606811Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-07-30
07899258606828Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-07-30
07899258606835Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-07-30
07899258606842Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-07-30
07899258606859Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-07-30
07899258606866Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-07-30
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