FDA.reportPublic FDA data

Endo-Model Knee System - Instruments

Primary DI
04026575046027
Brand
Endo-Model Knee System - Instruments
Company
WALDEMAR LINK GmbH & Co. KG
Model
15-2540
Device description
Orthopaedic implant driver - Endo Model Knee System
Published
2022-12-20
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
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
04026575046027PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04026575046027040265750460274026575046027

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implant driverA hand-held manual surgical instrument designed to impart force to an orthopaedic implantable device that is inserted to fix or fasten together bones. The device is frequently used to insert devices such as screws, nails, plates, or wires that are used to fix fractured or damaged bones and/or to attach orthopaedic prostheses to the bones. It is typically made of high-grade stainless steel or titanium (Ti). This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
315675488
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#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04026575448678MobileLink Acetabular Cup System183-353/40183-353/402026-07-09
04026575448685MobileLink Acetabular Cup System183-363/40183-363/402026-07-09
04026575448760MobileLink Acetabular Cup System183-354/40183-354/402026-07-09
04026575448777MobileLink Acetabular Cup System183-355/40183-355/402026-07-09
04026575448784MobileLink Acetabular Cup System183-356/40183-356/402026-07-09
04026575448791MobileLink Acetabular Cup System183-364/40183-364/402026-07-09
04026575448807MobileLink Acetabular Cup System183-365/40183-365/402026-07-09
04026575448814MobileLink Acetabular Cup System183-366/40183-366/402026-07-09
04026575448821MobileLink Acetabular Cup System183-373/40183-373/402026-07-09
04026575448838MobileLink Acetabular Cup System183-374/40183-374/402026-07-09
04026575448845MobileLink Acetabular Cup System183-375/40183-375/402026-07-09
04026575448852MobileLink Acetabular Cup System183-376/40183-376/402026-07-09
04026575448869MobileLink Acetabular Cup System183-743/40183-743/402026-07-09
04026575448876MobileLink Acetabular Cup System183-744/40183-744/402026-07-09
04026575448883MobileLink Acetabular Cup System183-745/40183-745/402026-07-09
04026575448890MobileLink Acetabular Cup System183-746/40183-746/402026-07-09
04026575348213SPII Model Lubinus128-950/35128-950/352015-11-01
04026575348220SPII Model Lubinus128-951/35128-951/352015-11-01
04026575348237SPII Model Lubinus128-952/35128-952/352015-11-01
04026575348244SPII Model Lubinus128-953/35128-953/352015-11-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810130207435MSIModern Surgical Instruments LLCLXH2026-07-14
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