LINK Instrument 317-802/63

GUDID 04026575382576

Femoral Control Block

WALDEMAR LINK GmbH & Co. KG

Orthopaedic prosthesis implantation instrument, reusable

• Primary Device ID: 04026575382576
• NIH Device Record Key: b28331f4-e216-4cc2-adf4-f1a17d2cac1f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LINK Instrument
• Version Model Number: 317-802/63
• Catalog Number: 317-802/63
• Company DUNS: 315675488
• Company Name: WALDEMAR LINK GmbH & Co. KG
• Device Count: 1
• DM Exempt: false
• 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: true
• Expiration Date: false
• 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	04026575382576 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182872

FDA Product Code

• JWH: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER

Sterilization

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

[04026575382576]

Moist Heat or Steam Sterilization

[04026575382576]

Moist Heat or Steam Sterilization

[04026575382576]

Moist Heat or Steam Sterilization

[04026575382576]

Moist Heat or Steam Sterilization

[04026575382576]

Moist Heat or Steam Sterilization

[04026575382576]

Moist Heat or Steam Sterilization

[04026575382576]

Moist Heat or Steam Sterilization

[04026575382576]

Moist Heat or Steam Sterilization

[04026575382576]

Moist Heat or Steam Sterilization

[04026575382576]

Moist Heat or Steam Sterilization

[04026575382576]

Moist Heat or Steam Sterilization

[04026575382576]

Moist Heat or Steam Sterilization

[04026575382576]

Moist Heat or Steam Sterilization

[04026575382576]

Moist Heat or Steam Sterilization

[04026575382576]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-05-08
• Device Publish Date: 2019-04-18

On-Brand Devices [LINK Instrument]

• 04026575185924: Impactor
• 04026575259434: Screw
• 04026575259427: Screw
• 04026575259106: Trial Neck
• 04026575259090: Trial Neck
• 04026575258024: Screw
• 04026575182190: Trial Stem
• 04026575182183: Trial Stem
• 04026575182176: Trial Stem
• 04026575182169: Trial Stem
• 04026575182152: Trial Stem
• 04026575182145: Trial Stem
• 04026575182138: Trial Stem
• 04026575182121: Trial Stem
• 04026575182114: Trial Stem
• 04026575182107: Trial Stem
• 04026575182091: Trial Stem
• 04026575182084: Trial Stem
• 04026575181964: Trial Neck
• 04026575181957: Trial Neck
• 04026575181940: Trial Neck
• 04026575181933: Trial Neck
• 04026575437412: Trial Plateau
• 04026575437405: Spacer
• 04026575437399: Spacer
• 04026575437382: Spacer
• 04026575437375: Spacer
• 04026575437368: Distal Cutting Block
• 04026575434282: Femoral Trial Box
• 04026575434275: Femoral Trial Box
• 04026575434268: Femoral Trial Box
• 04026575434251: Femoral Trial Box
• 04026575434244: Femoral Trial Box
• 04026575434237: Femoral Trial Box
• 04026575434220: Femoral Trial Box
• 04026575434213: Femoral Trial Box
• 04026575432318: Femoral Sizer
• 04026575429387: Cutting Block
• 04026575429370: Cutting Block
• 04026575429363: Cutting Block
• 04026575420278: Cutting Block
• 04026575420261: Cutting Block
• 04026575420254: Cutting Block
• 04026575420247: Tibial Base Guide
• 04026575420216: Cutting Block
• 04026575420209: Cutting Block
• 04026575420193: Cutting Block
• 04026575420186: Cutting Block
• 04026575420179: Cutting Block
• 04026575420162: Cutting Block