Spectron 71365092
GUDID 03596010199553
SPECTRON EF 12/14 TRIAL NECK HIGH OFFSET SIZE 2
Smith & Nephew, Inc.
Femoral stem prosthesis trial| Primary Device ID | 03596010199553 |
| NIH Device Record Key | 55a42d54-0d98-46b8-86bb-2a601c7115bd |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Spectron |
| Version Model Number | 71365092 |
| Catalog Number | 71365092 |
| 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 | |
| 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 | 03596010199553 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K123598
FDA Product Code
| JDG | Prosthesis, hip, femoral component, cemented, metal |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[03596010199553]
Moist Heat or Steam Sterilization
[03596010199553]
Moist Heat or Steam Sterilization
[03596010199553]
Moist Heat or Steam Sterilization
[03596010199553]
Moist Heat or Steam Sterilization
[03596010199553]
Moist Heat or Steam Sterilization
[03596010199553]
Moist Heat or Steam Sterilization
[03596010199553]
Moist Heat or Steam Sterilization
[03596010199553]
Moist Heat or Steam Sterilization
[03596010199553]
Moist Heat or Steam Sterilization
[03596010199553]
Moist Heat or Steam Sterilization
[03596010199553]
Moist Heat or Steam Sterilization
[03596010199553]
Moist Heat or Steam Sterilization
[03596010199553]
Moist Heat or Steam Sterilization
[03596010199553]
Moist Heat or Steam Sterilization
[03596010199553]
Moist Heat or Steam Sterilization
[03596010199553]
Moist Heat or Steam Sterilization
[03596010199553]
Moist Heat or Steam Sterilization
[03596010199553]
Moist Heat or Steam Sterilization
[03596010199553]
Moist Heat or Steam Sterilization
[03596010199553]
Moist Heat or Steam Sterilization
[03596010199553]
Moist Heat or Steam Sterilization
[03596010199553]
Moist Heat or Steam Sterilization
[03596010199553]
Moist Heat or Steam Sterilization
[03596010199553]
Moist Heat or Steam Sterilization
[03596010199553]
Moist Heat or Steam Sterilization
[03596010199553]
Moist Heat or Steam Sterilization
[03596010199553]
Moist Heat or Steam Sterilization
[03596010199553]
Moist Heat or Steam Sterilization
[03596010199553]
Moist Heat or Steam Sterilization
[03596010199553]
Moist Heat or Steam Sterilization
[03596010199553]
Moist Heat or Steam Sterilization
[03596010199553]
Moist Heat or Steam Sterilization
[03596010199553]
Moist Heat or Steam Sterilization
[03596010199553]
Moist Heat or Steam Sterilization
[03596010199553]
Moist Heat or Steam Sterilization
[03596010199553]
Moist Heat or Steam Sterilization
[03596010199553]
Moist Heat or Steam Sterilization
[03596010199553]
Moist Heat or Steam Sterilization
[03596010199553]
Moist Heat or Steam Sterilization
[03596010199553]
Moist Heat or Steam Sterilization
[03596010199553]
Moist Heat or Steam Sterilization
[03596010199553]
Moist Heat or Steam Sterilization
[03596010199553]
Moist Heat or Steam Sterilization
[03596010199553]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2020-11-03 |
| Device Publish Date | 2015-08-30 |
On-Brand Devices [Spectron]
| 00885556659380 | OFFSET SPECTRON STEM INSERTER |
| 00885556125359 | 12/14 SPECTRON REFL FINISH STEM STD OFFSET SZ 1 |
| 00885556110492 | SPECTRON EF 12/14 COLLARLESS TRIAL NECK SZ 1 |
| 00885556059814 | SPEC EF PRI STD 12/14 SIZE 1 W/GLASSBEAD |
| 00885556059043 | SPEC EF PRI HO 12/14 SIZE 1 W/GLASSBEAD |
| 00885556058565 | SPEC EF PRI STD 12/14 SIZE 5 W/GLASSBEAD |
| 00885556058312 | SPEC EF PRI HO 12/14 SIZE 5 W/GLASSBEAD |
| 00885556058190 | SPEC EF PRI STD 12/14 SIZE 4 W/GLASSBEAD |
| 00885556058060 | SPEC EF PRI HO 12/14 SIZE 4 W/GLASSBEAD |
| 00885556057919 | SPEC EF PRI HO 12/14 SIZE 3 W/GLASSBEAD |
| 00885556057872 | SPEC EF PRI STD 12/14 SIZE 3 W/GLASSBEAD |
| 00885556057766 | SPEC EF PRI HO 12/14 SIZE 2 W/GLASSBEAD |
| 00885556057735 | SPEC EF PRI STD 12/14 SIZE 2 W/GLASSBEAD |
| 00885556044896 | 12/14 SPECTRON REFL FINISH STEM HIGH OFFSET SZ 1 |
| 00885556044834 | 12/14 SPECTRON REFL FINISH STEM HIGH OFFSET SZ 5 |
| 00885556044698 | 12/14 SPECTRON REFL FINISH STEM STD OFFSET SZ 5 |
| 00885556044650 | 12/14 SPECTRON REFL FINSIH STEM HIGH OFFSET SZ 4 |
| 00885556044544 | 12/14 SPECTRON REFL FINISH STEM STD OFFSET SZ 4 |
| 00885556044438 | 12/14 SPECTRON REFL FINISH STEM STD OFFSET SZ 3 |
| 00885556044360 | 12/14 SPECTRON REFL FINISH STEM HIGH OFFSET SZ 3 |
| 00885556044131 | 12/14 SPECTRON REFL FINISH STEM STD OFFSET SZ 2 |
| 00885556043905 | 12/14 SPECTRON REFL FINSIH STEM HIGH OFFSET SZ 2 |
| 03596010058805 | SPECTRON EF FEMORAL DRIVER |
| 03596010058133 | SPECTRON EF PROBING DISSECTOR |
| 03596010485717 | SPECTRON EF CALIBRATED GUIDE ROD/BUCK PLUG 35MM |
| 03596010485700 | SPECTRON EF CALIBRATED GUIDE ROD/BUCK PLUG 30MM |
| 03596010485694 | SPECTRON EF CALIBRATED GUIDE ROD/BUCK PLUG 25MM |
| 03596010473479 | SPECTRON EF GUIDE ROD/BUCKPLUG 25MM |
| 03596010473455 | SPECTRON EF GUIDE ROD/BUCK PLUG 35MM |
| 03596010473448 | SPECTRON EF GUIDE ROD/BUCK PLUG30MM |
| 03596010466761 | 12/14 SPECTRON CDH SMALL 115MM FEMORAL COMPONENT |
| 03596010420008 | SPEC EF IMP GRAFT GUIDE ROD RATCHET HANDLE SOCKET |
| 03596010410627 | SPECTRON EF 12/14 LNG STR/NK REPL BRCH 165MM LARGE |
| 03596010409089 | SPECTRON 12/14 REVISION NECK REPL BROACH 135MM LG |
| 03596010398130 | SPECTRON EF 12/14 NK REPLACEMENT TRIAL NECK MED/LG |
| 03596010398123 | SPECTRON EF 12/14 NK REPLACEMENT TRIAL NECK SMALL |
| 03596010386656 | SPECTRON EF 12/14 TPR NECK REPLACEMENT 225MM LARGE |
| 03596010386618 | SPECTRON EF 12/14 TPR NECK REPLACEMENT 225MM SMALL |
| 03596010386557 | SPECTRON EF 12/14 TPR NECK REPLACEMENT 195MM MED |
| 03596010386533 | SPECTRON EF 12/14 TPR NECK REPLACEMENT 195MM SMALL |
| 03596010386458 | SPECTRON EF 12/14 TPR NECK REPLACEMENT 135MM SMALL |
| 03596010386410 | SPECTRON EF 12/14 TPR LONG STRAIGHT 195MM LARGE |
| 03596010306609 | SPECTRON EF 12/14 STAND OFFSET PRIMARY INST TRAY |
| 03596010199638 | SPECTRON EF 12/14 COLLARLESS TRIAL NECK SZ 5 |
| 03596010199416 | SPECTRON EF SIZE 4-5 CALCAR REAMER |
| 03596010199409 | SPECTRON MEDIUM CALCAR REAMER |
| 03596010199348 | SPECTRON EF SIZE 5 BROACH/TRIAL |
| 03596010199331 | SPECTRON EF SIZE 4 BROACH/TRIAL |
| 03596010199324 | SPECTRON EF SIZE 3 BROACH/TRIAL |
| 03596010199317 | SPECTRON EF SIZE 2 BROACH/TRIAL |
Trademark Results [Spectron]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SPECTRON 88981416 not registered Live/Pending |
OTOY, Inc. 2018-07-27 |
 SPECTRON 88055579 not registered Live/Pending |
OTOY, Inc. 2018-07-27 |
 SPECTRON 81037316 1037316 Dead/Cancelled |
Asahi Kogaku Kogyo Kabushiki Kaisha 0000-00-00 |
 SPECTRON 79123579 4574011 Live/Registered |
Spectron Gas Control Systems GmbH 2012-12-14 |
 SPECTRON 79117037 not registered Dead/Abandoned |
"SPECTRON" NPO" LTD 2012-07-09 |
 SPECTRON 79071153 3879226 Dead/Cancelled |
PELLENC 2009-02-12 |
 SPECTRON 78930202 3700432 Live/Registered |
SIEMENS AKTIENGESELLSCHAFT 2006-07-14 |
 SPECTRON 77957143 4192370 Dead/Cancelled |
PELLENC 2010-03-11 |
 SPECTRON 74620165 not registered Dead/Abandoned |
SpecTron Communications Corporation 1995-01-11 |
 SPECTRON 74529481 1974537 Dead/Cancelled |
UOP 1994-05-25 |
 SPECTRON 74389664 1854264 Live/Registered |
CORTLAND LINE COMPANY, INC. 1993-05-13 |
 SPECTRON 73749383 1579087 Dead/Cancelled |
SHAW INDUSTRIES, INC. 1988-08-31 |
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