LINK Embrace Shoulder System 643-242/10
GUDID 04026575238729
Reverse Inserts, inclined 10°, E-Dur
WALDEMAR LINK GmbH & Co. KG
Polyethylene reverse shoulder prosthesis cup| Primary Device ID | 04026575238729 |
| NIH Device Record Key | e73ee5b8-c7d1-49f5-bda4-4dc448955682 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | LINK Embrace Shoulder System |
| Version Model Number | 643-242/10 |
| Catalog Number | 643-242/10 |
| 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 | 04026575238729 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K200368
FDA Product Code
| HSD | PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED |
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 | 2021-04-01 |
| Device Publish Date | 2021-03-24 |
On-Brand Devices [LINK Embrace Shoulder System]
| 04026575302253 | Bone Screws, and Central Cancellous Bone Screw, Co |
| 04026575302239 | Bone Screws, and Central Cancellous Bone Screw, Co |
| 04026575302215 | Bone Screws, and Central Cancellous Bone Screw, Co |
| 04026575302192 | Bone Screws, and Central Cancellous Bone Screw, Co |
| 04026575302178 | Bone Screws, and Central Cancellous Bone Screw, Ca |
| 04026575302154 | Bone Screws, and Central Cancellous Bone Screw, Ca |
| 04026575285877 | Bone Screws, and Central Cancellous Bone Screw, Ce |
| 04026575285860 | Bone Screws, and Central Cancellous Bone Screw, Ce |
| 04026575285853 | Bone Screws, and Central Cancellous Bone Screw, Ce |
| 04026575260843 | Humeral Short Stems |
| 04026575260836 | Humeral Short Stems |
| 04026575260829 | Humeral Short Stems |
| 04026575260805 | Humeral Short Stems |
| 04026575260799 | Humeral Short Stems |
| 04026575260782 | Humeral Short Stems |
| 04026575260775 | Humeral Short Stems |
| 04026575260768 | Humeral Short Stems |
| 04026575260744 | Humeral Short Stems |
| 04026575242641 | Reverse Glenoid Baseplate |
| 04026575242634 | Humeral Standard Stems |
| 04026575242627 | Humeral Standard Stems |
| 04026575242429 | Humeral Standard Stems |
| 04026575242412 | Humeral Standard Stems |
| 04026575242405 | Humeral Standard Stems |
| 04026575242399 | Humeral Standard Stems |
| 04026575242382 | Humeral Standard Stems |
| 04026575242375 | Humeral Standard Stems |
| 04026575242368 | Humeral Standard Stems |
| 04026575242351 | Humeral Standard Stems |
| 04026575242344 | Humeral Standard Stems |
| 04026575242337 | Humeral Standard Stems |
| 04026575242320 | Humeral Standard Stems |
| 04026575241095 | Glenospheres, eccentric |
| 04026575241071 | Glenospheres, eccentric |
| 04026575241057 | Glenospheres, eccentric |
| 04026575240777 | Glenospheres, neutral |
| 04026575240760 | Glenospheres, neutral |
| 04026575240722 | Glenospheres, neutral |
| 04026575240692 | Bone Screws, and Central Cancellous Bone Screw, Co |
| 04026575240685 | Bone Screws, and Central Cancellous Bone Screw, Co |
| 04026575240678 | Bone Screws, and Central Cancellous Bone Screw, Co |
| 04026575240661 | Bone Screws, and Central Cancellous Bone Screw, Co |
| 04026575240654 | Bone Screws, and Central Cancellous Bone Screw, Co |
| 04026575240647 | Bone Screws, and Central Cancellous Bone Screw, Co |
| 04026575240630 | Bone Screws, and Central Cancellous Bone Screw, Co |
| 04026575240579 | Bone Screws, and Central Cancellous Bone Screw, Co |
| 04026575240524 | Bone Screws, and Central Cancellous Bone Screw, Co |
| 04026575240517 | Bone Screws, and Central Cancellous Bone Screw, Co |
| 04026575240494 | Bone Screws, and Central Cancellous Bone Screw, Ca |
| 04026575240487 | Bone Screws, and Central Cancellous Bone Screw, Ca |
Trademark Results [LINK Embrace Shoulder System]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 LINK EMBRACE SHOULDER SYSTEM 79367011 not registered Live/Pending |
WALDEMAR LINK GmbH & Co. KG 2023-03-03 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.