TrabecuLink Femoral Cones 15-3991/01

GUDID 04026575265107

TrabecuLink Femoral Cones / 3-zones left

WALDEMAR LINK GmbH & Co. KG

Knee arthroplasty wedge Knee arthroplasty wedge Knee arthroplasty wedge Knee arthroplasty wedge Knee arthroplasty wedge Knee arthroplasty wedge Knee arthroplasty wedge Knee arthroplasty wedge Knee arthroplasty wedge Knee arthroplasty wedge Knee arthroplasty wedge Knee arthroplasty wedge Knee arthroplasty wedge Knee arthroplasty wedge Knee arthroplasty wedge

• Primary Device ID: 04026575265107
• NIH Device Record Key: 0ee17689-7ce7-4155-87fa-b96de713ddd9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TrabecuLink Femoral Cones
• Version Model Number: 15-3991/01
• Catalog Number: 15-3991/01
• 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	04026575265107 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201364

FDA Product Code

• MBH: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-01-20
• Device Publish Date: 2021-01-12

On-Brand Devices [TrabecuLink Femoral Cones]

• 04026575265497: TrabecuLink Femoral Cones / 3-zones right
• 04026575265459: TrabecuLink Femoral Cones / 3-zones right
• 04026575265428: TrabecuLink Femoral Cones / 3-zones right
• 04026575265381: TrabecuLink Femoral Cones / 3-zones right
• 04026575265367: TrabecuLink Femoral Cones / 3-zones left
• 04026575265336: TrabecuLink Femoral Cones / 3-zones left
• 04026575265312: TrabecuLink Femoral Cones / 3-zones left
• 04026575265305: TrabecuLink Femoral Cones / 3-zones left
• 04026575265299: TrabecuLink Femoral Cones / 3-zones right
• 04026575265275: TrabecuLink Femoral Cones / 3-zones right
• 04026575265251: TrabecuLink Femoral Cones / 3-zones right
• 04026575265244: TrabecuLink Femoral Cones / 3-zones right
• 04026575265237: TrabecuLink Femoral Cones / 3-zones left
• 04026575265220: TrabecuLink Femoral Cones / 3-zones left
• 04026575265213: TrabecuLink Femoral Cones / 3-zones left
• 04026575265206: TrabecuLink Femoral Cones / 3-zones left
• 04026575265190: TrabecuLink Femoral Cones / 3-zones right
• 04026575265183: TrabecuLink Femoral Cones / 3-zones right
• 04026575265176: TrabecuLink Femoral Cones / 3-zones right
• 04026575265145: TrabecuLink Femoral Cones / 3-zones right
• 04026575265138: TrabecuLink Femoral Cones / 3-zones left
• 04026575265121: TrabecuLink Femoral Cones / 3-zones left
• 04026575265114: TrabecuLink Femoral Cones / 3-zones left
• 04026575265107: TrabecuLink Femoral Cones / 3-zones left
• 04026575182480: TrabecuLink Femoral Cones / 2-zones
• 04026575182473: TrabecuLink Femoral Cones / Proximal
• 04026575182466: TrabecuLink Femoral Cones / 2-zones
• 04026575182459: TrabecuLink Femoral Cones / 2-zones
• 04026575182442: TrabecuLink Femoral Cones / 2-zones
• 04026575182435: TrabecuLink Femoral Cones / Proximal
• 04026575182428: TrabecuLink Femoral Cones / 2-zones
• 04026575182411: TrabecuLink Femoral Cones / 2-zones