LINK Endo-Model EVO Knee System

GUDID 04026575302260

WALDEMAR LINK GmbH & Co. KG

Implantable orthopaedic/craniofacial device connection screw

• Primary Device ID: 04026575302260
• NIH Device Record Key: 348c4b42-680d-4380-8163-be557c879cf4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LINK Endo-Model EVO Knee System
• Version Model Number: 15-0037/30
• Company DUNS: 315675488
• Company Name: WALDEMAR LINK GmbH & Co. KG
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04026575302260 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K220628

FDA Product Code

• KRO: PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2025-06-09
• Device Publish Date: 2023-01-26

On-Brand Devices [LINK Endo-Model EVO Knee System]

• 04026575302277: 15-0037/31
• 04026575302260: 15-0037/30
• 04026575298709: 15-3900/02
• 04026575274666: 15-9537/17
• 04026575274659: 15-9537/16
• 04026575274642: 15-9537/15
• 04026575274635: 15-9537/14
• 04026575274628: Replacement set, CoCrMo, UHMWPE, rotating hinge tibial plateau with plateau screw (EVO)
• 04026575274611: Replacement set, CoCrMo, UHMWPE, rotating hinge tibial plateau with plateau screw (EVO)
• 04026575274604: Replacement set, CoCrMo, UHMWPE, rotating hinge tibial plateau with plateau screw (EVO)
• 04026575274598: Replacement set, CoCrMo, UHMWPE, rotating hinge tibial plateau with plateau screw (EVO)
• 04026575186235: 15-3900/01
• 04026575301744: Replacement set, CoCrMo, UHMWPE, rotating hinge (EVO)
• 04026575301720: Replacement set, CoCrMo, UHMWPE, rotating hinge (EVO)
• 04026575301706: Replacement set, CoCrMo, UHMWPE, rotating hinge (EVO)
• 04026575301683: Replacement set, CoCrMo, UHMWPE, rotating hinge (EVO)
• 04026575275571: Modular stem, uncemented, Ti6Al4V, cylindrical (EVO)
• 04026575275465: Modular stem, uncemented, Ti6Al4V, cylindrical (EVO)
• 04026575274796: Replacement set, CoCrMo, UHMWPE, Ti6Al4V, for LINK Endo-Model EVO, pure hinge with security scr
• 04026575274772: Replacement set, CoCrMo, UHMWPE, Ti6Al4V, for LINK Endo-Model EVO, pure hinge with security scr
• 04026575274758: Replacement set, CoCrMo, UHMWPE, Ti6Al4V, for LINK Endo-Model EVO, pure hinge with security scr
• 04026575274734: Replacement set, CoCrMo, UHMWPE, Ti6Al4V, for LINK Endo-Model EVO, pure hinge with security scr
• 04026575274710: Replacement set, CoCrMo, UHMWPE, Ti6Al4V, for LINK Endo-Model EVO, pure hinge with security scr
• 04026575274697: Replacement set, CoCrMo, UHMWPE, Ti6Al4V, for LINK Endo-Model EVO, pure hinge with security scr
• 04026575274680: Replacement set, CoCrMo, UHMWPE, Ti6Al4V, for LINK Endo-Model EVO, pure hinge with security scr
• 04026575274673: Replacement set, CoCrMo, UHMWPE, Ti6Al4V, for LINK Endo-Model EVO, pure hinge with security scr
• 04026575268627: Proximal tibial spacer, uncemented, Ti6Al4V, for rotating hinge and pure hinge, half (EVO)
• 04026575268603: Proximal tibial spacer, uncemented, Ti6Al4V, for rotating hinge and pure hinge, half (EVO)
• 04026575268597: Proximal tibial spacer, uncemented, Ti6Al4V, for rotating hinge and pure hinge, half (EVO)
• 04026575268573: Proximal tibial spacer, uncemented, Ti6Al4V, for rotating hinge and pure hinge, full (EVO)
• 04026575268566: Proximal tibial spacer, uncemented, Ti6Al4V, for rotating hinge and pure hinge, full (EVO)
• 04026575268559: Proximal tibial spacer, uncemented, Ti6Al4V, for rotating hinge and pure hinge, full (EVO)
• 04026575268542: Proximal tibial spacer, uncemented, Ti6Al4V, for rotating hinge and pure hinge, full (EVO)
• 04026575268054: Tibial component, cemented, CoCrMo, UHMWPE, standard, pure hinge (EVO)
• 04026575268047: Tibial component, cemented, CoCrMo, UHMWPE, standard, pure hinge (EVO)
• 04026575268030: Tibial component, cemented, CoCrMo, UHMWPE, standard, pure hinge (EVO)
• 04026575268023: Tibial component, cemented, CoCrMo, UHMWPE, standard, pure hinge (EVO)
• 04026575268016: Femoral component, cemented, CoCrMo, UHMWPE, Ti6Al4V, standard, pure hinge (EVO)
• 04026575268009: Femoral component, cemented, CoCrMo, UHMWPE, Ti6Al4V, standard, pure hinge (EVO)
• 04026575267996: Femoral component, cemented, CoCrMo, UHMWPE, Ti6Al4V, standard, pure hinge (EVO)
• 04026575267989: Femoral component, cemented, CoCrMo, UHMWPE, Ti6Al4V, standard, pure hinge (EVO)
• 04026575267972: Femoral component, cemented, CoCrMo, UHMWPE, Ti6Al4V, standard, pure hinge (EVO)
• 04026575267965: Femoral component, cemented, CoCrMo, UHMWPE, Ti6Al4V, standard, pure hinge (EVO)
• 04026575267958: Femoral component, cemented, CoCrMo, UHMWPE, Ti6Al4V, standard, pure hinge (EVO)
• 04026575267941: Femoral component, cemented, CoCrMo, UHMWPE, Ti6Al4V, standard, pure hinge (EVO)
• 04026575185887: Proximal tibial spacer, uncemented, Ti6Al4V, for rotating hinge and pure hinge, full (EVO)
• 04026575185856: Proximal tibial spacer, uncemented, Ti6Al4V, for rotating hinge and pure hinge, full (EVO)
• 04026575185825: Proximal tibial spacer, uncemented, Ti6Al4V, for rotating hinge and pure hinge, full (EVO)
• 04026575185788: Proximal tibial spacer, uncemented, Ti6Al4V, for rotating hinge and pure hinge, full (EVO)
• 04026575185740: Proximal tibial spacer, uncemented, Ti6Al4V, for rotating hinge and pure hinge, full (EVO)