POLARSTEM 75018404
GUDID 07611996103410
POLARSTEM Stem Standard Ti/HA with Collar 4
Smith & Nephew, Inc.
Coated hip femur prosthesis, modular| Primary Device ID | 07611996103410 |
| NIH Device Record Key | 8940ea87-628a-41ab-9c56-9c6dbdac1045 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | POLARSTEM |
| Version Model Number | 75018404 |
| Catalog Number | 75018404 |
| 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 | 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 | |
| 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 | 07611996103410 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K143739
FDA Product Code
| LWJ | Prosthesis, hip, semi-constrained, metal/polymer, uncemented |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2016-07-25 |
On-Brand Devices [POLARSTEM]
| 00885556590317 | FIN STABILIZER FOR 75000675 |
| 00885556535578 | POLARSTEM STEM IMPACTOR CURVED |
| 00885556535530 | POLARSTEM TRIAL NECK COLLAR LAT 1-11 |
| 00885556535523 | POLARSTEM COLLAR CALCAR REAMER LARGE |
| 00885556535516 | POLARSTEM COLLAR CALCAR REAMER SMALL |
| 00885556535493 | POLARSTEM COLLAR REAMER GUIDE |
| 00885556535486 | POLARSTEM TRIAL NECK COLLAR STD 1-11 |
| 00885556535479 | POLARSTEM TRIAL NECK COLLAR STD 0 |
| 00885556535448 | POLARSTEM COLLAR CASE |
| 00885556535424 | DAA DOUBLE OFFSET ADAPTER LEFT 80/45 |
| 00885556535417 | POLARSTEM KNOCK PLATE LARGE |
| 00885556535400 | POLARSTEM STARTER RASP |
| 00885556535394 | DAA DOUBLE OFFSET ADAPTER RIGHT 80/45 |
| 07611996162714 | Cardan for 21000438 |
| 07611996153040 | TRIAL NECK VALGUS 0-7 |
| 07611996152715 | POLARSTEM Stem Lateral Ti/HA with Collar 11 |
| 07611996152708 | POLARSTEM Stem Lateral Ti/HA with Collar 10 |
| 07611996152692 | POLARSTEM Stem Lateral Ti/HA with Collar 9 |
| 07611996142396 | POLARSTEM VALGUS TI/HA 7 |
| 07611996142389 | POLARSTEM VALGUS TI/HA 6 |
| 07611996142372 | POLARSTEM VALGUS TI/HA 5 |
| 07611996142365 | POLARSTEM VALGUS TI/HA 4 |
| 07611996142358 | POLARSTEM VALGUS TI/HA 3 |
| 07611996142341 | POLARSTEM VALGUS TI/HA 2 |
| 07611996142334 | POLARSTEM VALGUS TI/HA 1 |
| 07611996142327 | POLARSTEM VALGUS TI/HA 0 |
| 07611996118933 | POLARSTEM STEM LAT.TI/HA 11 NON-CEM |
| 07611996118926 | POLARSTEM STEM STD TI/HA 11 NON-CEM |
| 07611996118742 | POLARSTEM STEM LAT.TI/HA 10 NON-CEM |
| 07611996118735 | POLARSTEM STEM LAT.TI/HA 9 NON-CEM |
| 07611996118728 | POLARSTEM STEM LAT.TI/HA 8 NON-CEM |
| 07611996118711 | POLARSTEM STEM LAT.TI/HA 7 NON-CEM |
| 07611996118704 | POLARSTEM STEM LAT.TI/HA 6 NON-CEM |
| 07611996118698 | POLARSTEM STEM LAT.TI/HA 5 NON-CEM |
| 07611996118681 | POLARSTEM STEM LAT.TI/HA 4 NON-CEM |
| 07611996118674 | POLARSTEM STEM LAT.TI/HA 3 NON-CEM |
| 07611996118667 | POLARSTEM STEM LAT.TI/HA 2 NON-CEM |
| 07611996118650 | POLARSTEM STEM LAT.TI/HA 1 NON-CEM |
| 07611996118643 | POLARSTEM STEM STD TI/HA 10 NON-CEM |
| 07611996118636 | POLARSTEM STEM STANDARD TI/HA 9 NON-CEM |
| 07611996118629 | POLARSTEM STEM STANDARD TI/HA 8 NON-CEM |
| 07611996118612 | POLARSTEM STEM STANDARD TI/HA 7 NON-CEM |
| 07611996118605 | POLARSTEM STEM STANDARD TI/HA 6 NON-CEM |
| 07611996118599 | POLARSTEM STEM STD TI/HA 5 NON-CEM |
| 07611996118582 | POLARSTEM STEM STANDARD TI/HA 4 NON-CEM |
| 07611996118575 | POLARSTEM STEM STANDARD TI/HA 3 NON-CEM |
| 07611996118568 | POLARSTEM STEM STANDARD TI/HA 2 NON-CEM |
| 07611996118551 | POLARSTEM STEM STANDARD TI/HA 1 NON-CEM |
| 07611996118544 | POLARSTEM STEM STANDARD TI/HA 0 NON-CEM |
| 07611996117097 | POLARSTEM TRAY FOR 75100213 |
Trademark Results [POLARSTEM]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 POLARSTEM 85547504 4475638 Live/Registered |
Smith & Nephew Orthopaedics AG 2012-02-20 |
 POLARSTEM 77391023 not registered Dead/Abandoned |
Smith & Nephew Orthopaedics AG 2008-02-07 |
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