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 Rotating hinged total knee prosthesis Rotating hinged total knee prosthesis Rotating hinged total knee prosthesis Rotating hinged total knee prosthesis Rotating hinged total knee prosthesis Rotating hinged total knee prosthesis 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