Journey XR E0015909-1
GUDID 00885556716199
XR LATERAL SAW CAPTURE - LEFT
Smith & Nephew, Inc.
Osteotomy guide| Primary Device ID | 00885556716199 |
| NIH Device Record Key | 17b5abb1-1a25-49d9-aca7-36b1f71bb5ce |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Journey XR |
| Version Model Number | E0015909-1 |
| Catalog Number | E0015909-1 |
| Company DUNS | 109903521 |
| 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 | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| 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 | |
| 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 | |
| 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 | 00885556716199 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K141471
FDA Product Code
| JWH | PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00885556716199]
Moist Heat or Steam Sterilization
[00885556716199]
Moist Heat or Steam Sterilization
[00885556716199]
Moist Heat or Steam Sterilization
[00885556716199]
Moist Heat or Steam Sterilization
[00885556716199]
Moist Heat or Steam Sterilization
[00885556716199]
Moist Heat or Steam Sterilization
[00885556716199]
Moist Heat or Steam Sterilization
[00885556716199]
Moist Heat or Steam Sterilization
[00885556716199]
Moist Heat or Steam Sterilization
[00885556716199]
Moist Heat or Steam Sterilization
[00885556716199]
Moist Heat or Steam Sterilization
[00885556716199]
Moist Heat or Steam Sterilization
[00885556716199]
Moist Heat or Steam Sterilization
[00885556716199]
Moist Heat or Steam Sterilization
[00885556716199]
Moist Heat or Steam Sterilization
[00885556716199]
Moist Heat or Steam Sterilization
[00885556716199]
Moist Heat or Steam Sterilization
[00885556716199]
Moist Heat or Steam Sterilization
[00885556716199]
Moist Heat or Steam Sterilization
[00885556716199]
Moist Heat or Steam Sterilization
[00885556716199]
Moist Heat or Steam Sterilization
[00885556716199]
Moist Heat or Steam Sterilization
[00885556716199]
Moist Heat or Steam Sterilization
[00885556716199]
Moist Heat or Steam Sterilization
[00885556716199]
Moist Heat or Steam Sterilization
[00885556716199]
Moist Heat or Steam Sterilization
[00885556716199]
Moist Heat or Steam Sterilization
[00885556716199]
Moist Heat or Steam Sterilization
[00885556716199]
Moist Heat or Steam Sterilization
[00885556716199]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2018-03-16 |
On-Brand Devices [Journey XR]
| 00885556716205 | XR LATERAL SAW CAPTURE - RIGHT |
| 00885556716199 | XR LATERAL SAW CAPTURE - LEFT |
Trademark Results [Journey XR]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 JOURNEY XR 85465793 not registered Dead/Abandoned |
Smith & Nephew, Inc. 2011-11-07 |
 JOURNEY XR 77381839 not registered Dead/Abandoned |
Smith & Nephew, Inc. 2008-01-28 |
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