EMPERION 71291689
GUDID 03596010561923
EMPERION 17 SLEEVE LARGE CONE 3 SPOUT
Smith & Nephew, Inc.
Coated hip femur prosthesis, modular| Primary Device ID | 03596010561923 |
| NIH Device Record Key | 4de11b02-3f5f-4424-824d-c515491c4b76 |
| Commercial Distribution Discontinuation | 2018-04-22 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | EMPERION |
| Version Model Number | 71291689 |
| Catalog Number | 71291689 |
| Company DUNS | 045483575 |
| Company Name | Smith & Nephew, Inc. |
| Device Count | 1 |
| DM Exempt | false |
| 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 | true |
| 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 |
Customer Support Contacts
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 03596010561923 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K042127
FDA Product Code
| MEH | Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2023-09-07 |
| Device Publish Date | 2015-08-29 |
On-Brand Devices [EMPERION]
| 00885556311844 | EMPERION 15 STEM PRIMARY REDUCED OFFSET |
| 00885556311790 | EMPERION 13 STEM PRIMARY REDUCED OFFSET |
| 00885556143940 | EMPERION SLEEVE TRIAL 11MM MED CONE SLOTTED ASSY |
| 00885556143933 | EMPERION SLEEVE TRIAL 11MM LG CONE SLOTTED ASSY |
| 00885556111475 | EMP 19 SM CONE 1 SPOUT TRIAL SLEEVE |
| 00885556066089 | EMPERION 19 STEM PRIMARY SO 18MM DISTAL |
| 00885556065808 | EMPERION 17 STEM PRIMARY HO 16MM DISTAL |
| 00885556065761 | EMPERION 17 STEM PRIMARY SO 16MM DISTAL |
| 00885556065556 | EMPERION 15 STEM PRIMARY HO 14MM DISTAL |
| 00885556065204 | EMPERION 15 STEM PRIMARY SO 14MM DISTAL |
| 00885556064962 | EMPERION 13 STEM PRIMARY HO 12MM DISTAL |
| 00885556064757 | EMPERION 13 STEM PRIMARY SO 12MM DISTAL |
| 00885556064733 | EMPERION 11 STEM PRIMARY HO 10MM DISTAL |
| 00885556064092 | EMPERION 19 STEM PRIMARY HO 18MM DISTAL |
| 00885556064078 | EMPERION 11 STEM PRIMARY SO 10MM DISTAL |
| 00885556060063 | EMPERION SLEEVE TRIAL 9MM LG CONE SLOTTED ASSY |
| 00885556059845 | EMPERION SLEEVE 11 MED CONE SLOTTED |
| 00885556059739 | EMPERION SLEEVE 11 SM CONE SLOTTED |
| 00885556059678 | EMPERION SLEEVE TRIAL 9MM MED CONE SLOTTED ASSY |
| 00885556059074 | EMPERION SLEEVE 13MM SM CONE SLOTTED |
| 00885556059005 | EMPERION SLEEVE TRIAL 9MM SM CONE SLOTTED ASSY |
| 00885556058985 | EMPERION SLEEVE 9 LG CONE SLOTTED |
| 00885556058978 | EMPERION SLEEVE TRIAL 13MM LG CONE SLOTTED ASSY |
| 00885556058640 | EMPERION SLEEVE TRIAL 13MM MED CONE SLOTTED ASSY |
| 00885556058435 | EMPERION SLEEVE 9 MED CONE SLOTTED |
| 00885556058411 | EMPERION SLEEVE 13MM LG CONE SLOTTED |
| 00885556058336 | EMPERION SLEEVE TRIAL 13MM SM CONE SLOTTED ASSY |
| 00885556058053 | EMPERION SLEEVE 13MM MED CONE SLOTTED |
| 00885556057964 | EMPERION SLEEVE TRIAL 11MM SM CONE SLOTTED ASSY |
| 00885556057902 | EMPERION SLEEVE 9 SM CONE SLOTTED |
| 00885556057889 | EMPERION SLEEVE 11 LG CONE SLOTTED |
| 00885556028940 | 20.5 MM THIN SHAFT REAMER |
| 00885556028889 | EMPERION 23 MED TALL TRIAL SLEEVE |
| 00885556028537 | 23 MM THIN SHAFT REAMER |
| 00885556028452 | EMPERION 21 MED TALL TRIAL SLEEVE |
| 00885556028230 | EMPERION 23S-21M TALL PROXIMAL REAMERS |
| 00885556027820 | 22.5 MM THIN SHAFT REAMER |
| 00885556027813 | EMPERION 23XL PROXIMAL REAMERS |
| 00885556027561 | EMPERION 21 SMALL TALL TRIAL SLEEVE |
| 00885556027516 | 22 MM THIN SHAFT REAMER |
| 00885556027493 | EMPERION 23L-21XL PROXIMAL REAMERS |
| 00885556027288 | 21.5 MM THIN SHAFT REAMER |
| 00885556027004 | 24 MM THIN SHAFT REAMER |
| 00885556026786 | EMPERION 22MM DISTAL REAMER |
| 00885556026779 | EMPERION 23M TALL PROXIMAL REAMER |
| 00885556026762 | 23.5 MM THIN SHAFT REAMER |
| 00885556026755 | 21 MM THIN SHAFT REAMER |
| 00885556026526 | EMPERION 23XL MILLER FRAME |
| 00885556026410 | EMPERION 23MM MED BOWED TRIAL SLEEVE |
| 00885556026373 | EMPERION 23L-21XL MILLER FRAME |
Trademark Results [EMPERION]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 EMPERION 98433478 not registered Live/Pending |
Emperion, Inc. 2024-03-05 |
 EMPERION 78481369 3110375 Dead/Cancelled |
Smith & Nephew, Inc. 2004-09-10 |
 EMPERION 74232017 1768231 Dead/Cancelled |
Emperion Corporation 1991-12-20 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.