TrabecuLink Femoral Cones 15-3995/01

GUDID 04026575265145

TrabecuLink Femoral Cones / 3-zones right

WALDEMAR LINK GmbH & Co. KG

Knee arthroplasty wedge

• Primary Device ID: 04026575265145
• NIH Device Record Key: e0e03d30-0774-4f71-bd81-85aaada936fe
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TrabecuLink Femoral Cones
• Version Model Number: 15-3995/01
• Catalog Number: 15-3995/01
• 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	04026575265145 [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