Endo-Model Standard Knee Prosthesis System 16-2011/22

GUDID 04026575222063

Sparepart Kit Boxes for Endo-Model SL

WALDEMAR LINK GmbH & Co. KG

Rotating hinged total knee prosthesis

• Primary Device ID: 04026575222063
• NIH Device Record Key: 6d85f800-09fb-4f9e-854f-06fd95265be1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Endo-Model Standard Knee Prosthesis System
• Version Model Number: 16-2011/22
• Catalog Number: 16-2011/22
• 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	04026575222063 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151008

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-08-23
• Device Publish Date: 2021-08-13

On-Brand Devices [Endo-Model Standard Knee Prosthesis System]

• 04026575253647: Tibial Plateau for Rotational Knee Prosthesis,Replacement Set
• 04026575253630: Tibial Plateau for Rotational Knee Prosthesis,Replacement Set
• 04026575253623: Tibial Plateau for Rotational Knee Prosthesis,Replacement Set
• 04026575214006: Centralizer,Set consisting of small, medium, large
• 04026575205967: Centralizer
• 04026575205950: Centralizer
• 04026575205943: Centralizer
• 04026575431632: Tibial Plateau for Rotational Knee Prosthesis
• 04026575431625: Tibial Plateau for Rotational Knee Prosthesis
• 04026575222933: Sparepart Kit Boxes for Endo-Model SL
• 04026575222926: Sparepart Kit Boxes for Endo-Model SL
• 04026575222230: Sparepart Kit Boxes for Endo-Model SL
• 04026575222070: Sparepart Kit Boxes for Endo-Model SL
• 04026575222063: Sparepart Kit Boxes for Endo-Model SL
• 04026575222049: Sparepart Kit Boxes for Endo-Model SL
• 04026575213429: Tibial Plateau for Rotational Knee Prosthesis
• 04026575213221: Tibial Plateau for Rotational Knee Prosthesis
• 04026575194698: Replacement Set, with anti-luxation device
• 04026575194681: Replacement Set, with anti-luxation device
• 04026575194674: Replacement Set, with anti-luxation device
• 04026575194667: Replacement Set, with anti-luxation device
• 04026575034710: Rotational Knee Joint Prosthesis
• 04026575034703: Rotational Knee Joint Prosthesis
• 04026575034697: Rotational Knee Joint Prosthesis
• 04026575034680: Rotational Knee Joint Prosthesis
• 04026575034673: Rotational Knee Joint Prosthesis
• 04026575034666: Rotational Knee Joint Prosthesis
• 04026575034659: Rotational Knee Joint Prosthesis
• 04026575031016: Rotational Knee Joint Prosthesis
• 04026575031009: Rotational Knee Replacement Set
• 04026575030996: Rotational Knee Replacement Set
• 04026575030095: Rotational Knee Replacement Set
• 04026575026555: Rotational Knee Replacement Set