Primary Device ID | 04026575274659 |
NIH Device Record Key | 9a945ce2-ee2f-4d3a-9870-e83af68f5c7c |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | LINK Endo-Model EVO Knee System |
Version Model Number | 15-9537/16 |
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 Issuing Agency | Device ID |
---|---|
GS1 | 04026575274659 [Primary] |
KRO | PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 2 |
Public Version Date | 2025-06-09 |
Device Publish Date | 2023-01-26 |
04026575302277 | 15-0037/31 |
04026575302260 | 15-0037/30 |
04026575298709 | 15-3900/02 |
04026575274666 | 15-9537/17 |
04026575274659 | 15-9537/16 |
04026575274642 | 15-9537/15 |
04026575274635 | 15-9537/14 |
04026575274628 | Replacement set, CoCrMo, UHMWPE, rotating hinge tibial plateau with plateau screw (EVO) |
04026575274611 | Replacement set, CoCrMo, UHMWPE, rotating hinge tibial plateau with plateau screw (EVO) |
04026575274604 | Replacement set, CoCrMo, UHMWPE, rotating hinge tibial plateau with plateau screw (EVO) |
04026575274598 | Replacement set, CoCrMo, UHMWPE, rotating hinge tibial plateau with plateau screw (EVO) |
04026575186235 | 15-3900/01 |