SPATIAL FRAME 71070340
GUDID 03596010459633
IDENTIFICATION BAND KIT FOR FAST FX STRUTS
Smith & Nephew, Inc.
External orthopaedic fixation system, single-use| Primary Device ID | 03596010459633 |
| NIH Device Record Key | 91b0b161-37d5-4135-bfe0-fd23332a68da |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SPATIAL FRAME |
| Version Model Number | 71070340 |
| Catalog Number | 71070340 |
| Company DUNS | 109903521 |
| Company Name | Smith & Nephew, Inc. |
| 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 | true |
| 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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 03596010459633 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K994143
FDA Product Code
| JDW | PIN, FIXATION, THREADED |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[03596010459633]
Moist Heat or Steam Sterilization
[03596010459633]
Moist Heat or Steam Sterilization
[03596010459633]
Moist Heat or Steam Sterilization
[03596010459633]
Moist Heat or Steam Sterilization
[03596010459633]
Moist Heat or Steam Sterilization
[03596010459633]
Moist Heat or Steam Sterilization
[03596010459633]
Moist Heat or Steam Sterilization
[03596010459633]
Moist Heat or Steam Sterilization
[03596010459633]
Moist Heat or Steam Sterilization
[03596010459633]
Moist Heat or Steam Sterilization
[03596010459633]
Moist Heat or Steam Sterilization
[03596010459633]
Moist Heat or Steam Sterilization
[03596010459633]
Moist Heat or Steam Sterilization
[03596010459633]
Moist Heat or Steam Sterilization
[03596010459633]
Moist Heat or Steam Sterilization
[03596010459633]
Moist Heat or Steam Sterilization
[03596010459633]
Moist Heat or Steam Sterilization
[03596010459633]
Moist Heat or Steam Sterilization
[03596010459633]
Moist Heat or Steam Sterilization
[03596010459633]
Moist Heat or Steam Sterilization
[03596010459633]
Moist Heat or Steam Sterilization
[03596010459633]
Moist Heat or Steam Sterilization
[03596010459633]
Moist Heat or Steam Sterilization
[03596010459633]
Moist Heat or Steam Sterilization
[03596010459633]
Moist Heat or Steam Sterilization
[03596010459633]
Moist Heat or Steam Sterilization
[03596010459633]
Moist Heat or Steam Sterilization
[03596010459633]
Moist Heat or Steam Sterilization
[03596010459633]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2021-11-23 |
| Device Publish Date | 2015-08-25 |
On-Brand Devices [SPATIAL FRAME]
| 00885556469347 | SPATIAL FRAME FULL RING 105MM GREEN |
| 00885556469293 | SPATIAL FRAME FULL RING 105MM BLUE |
| 00885556469248 | SPATIAL FRAME FULL RING 105MM PINK |
| 00885556209592 | TAYLOR SPATIAL FRAME 2/3 RING 275MM |
| 00885556209547 | TAYLOR SPATIAL FRAME HALF RING 275MM |
| 00885556209493 | TAYLOR SPATIAL FRAME FULL RING 275MM |
| 00885556209448 | TAYLOR SPATIAL FRAME 2/3 RING 255MM |
| 00885556209394 | TAYLOR SPATIAL FRAME HALF RING 255MM |
| 00885556209349 | TAYLOR SPATIAL FRAME FULL RING 255MM |
| 00885556145777 | SPATIAL FRAME 2/3 RING 180MM W/EXTRA HOLES |
| 00885556145715 | SPATIAL FRAME 2/3 RING 205MM W/EXTRA HOLES |
| 00885556145616 | SPATIAL FRAME U PLATE 80MM ID W/ EXTRA HOLES |
| 00885556126943 | SPATIAL FRAME 205 LONG |
| 00885556126936 | SPATIAL FRAME 155MM SHORT |
| 00885556126929 | SPATIAL FRAME 180MM SHORT |
| 00885556126912 | SPATIAL FOOT ACC RING 155MM |
| 00885556119587 | SPATIAL FRAME FULL RING 105MM |
| 00885556119570 | SPATIAL FRAME FULL RING 130MM |
| 00885556119563 | SPATIAL FRAME FULL RING 155MM |
| 00885556119556 | SPATIAL FRAME FULL RING 180MM |
| 00885556119549 | SPATIAL FRAME FULL RING 205MM |
| 00885556119532 | SPATIAL FRAME FULL RING 230MM |
| 00885556119525 | SPATIAL FRAME 2/3 RING 105MM |
| 00885556119518 | SPATIAL FRAME 2/3 RING 130MM |
| 00885556119198 | ATTACHMENT CALIBRATION SPHERE |
| 00885556119181 | EQUATOR CLAMP |
| 00885556119143 | SPATIAL FRAME 2/3 RING 155MM |
| 00885556119136 | SPATIAL FRAME 2/3 RING 180MM |
| 00885556119129 | SPATIAL FRAME 2/3 RING 205MM |
| 00885556119112 | SPATIAL FRAME 2/3 RING 230MM |
| 00885556066638 | TSF LONG FOOT PLATE 155MM RED |
| 00885556066560 | TSF LONG FOOT PLATE 155MM BLUE |
| 00885556066539 | TSF LONG FOOT PLATE 180MM GREEN |
| 00885556066423 | TSF 1/2 RING 180MM PINK |
| 00885556066355 | TSF LONG FOOT PLATE 180MM RED |
| 00885556066225 | TSF 1/2 RING 130MM PINK |
| 00885556066218 | TSF FULL RING 130MM PINK |
| 00885556066072 | TSF LONG FOOT PLATE 180MM BLUE |
| 00885556065938 | TSF 1/2 RING 180MM GREEN |
| 00885556065846 | TSF FULL RING 130MM GREEN |
| 00885556065709 | TSF LONG FOOT PLATE 155MM PINK |
| 00885556065440 | TSF 1/2 RING 180MM RED |
| 00885556065433 | TSF 1/2 RING 130MM GREEN |
| 00885556065297 | TSF FULL RING 130MM RED |
| 00885556065228 | TSF 1/2 RING 130MM RED |
| 00885556065129 | TAYLOR SPATIAL FULL RING 180MM PINK |
| 00885556065051 | TSF 1/2 RING 180MM BLUE |
| 00885556064924 | TAYLOR SPATIAL FULL RING 155MM PINK |
| 00885556064870 | TSF FULL RING 130MM BLUE |
| 00885556064474 | TAYLOR SPATIAL 2/3 RING 180MM PINK |
Trademark Results [SPATIAL FRAME]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SPATIAL FRAME 88119965 not registered Live/Pending |
Smith & Nephew, Inc. 2018-09-17 |
 SPATIAL FRAME 75139234 2417789 Dead/Cancelled |
SMITH & NEPHEW, INC. 1996-07-24 |
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