Spectron 71365098

GUDID 03596010398147

SPECTRON EF 12/14 LONG STRAIGHT TRIAL NECK SMALL

Smith & Nephew, Inc.

Femoral stem prosthesis trial

• Primary Device ID: 03596010398147
• NIH Device Record Key: 33ef3961-206c-43f5-90c6-c4cbb8012ce9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Spectron
• Version Model Number: 71365098
• Catalog Number: 71365098
• 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
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM

Device Identifiers

Device Issuing Agency	Device ID
GS1	03596010398147 [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

[03596010398147]

Moist Heat or Steam Sterilization

[03596010398147]

Moist Heat or Steam Sterilization

[03596010398147]

Moist Heat or Steam Sterilization

[03596010398147]

Moist Heat or Steam Sterilization

[03596010398147]

Moist Heat or Steam Sterilization

[03596010398147]

Moist Heat or Steam Sterilization

[03596010398147]

Moist Heat or Steam Sterilization

[03596010398147]

Moist Heat or Steam Sterilization

[03596010398147]

Moist Heat or Steam Sterilization

[03596010398147]

Moist Heat or Steam Sterilization

[03596010398147]

Moist Heat or Steam Sterilization

[03596010398147]

Moist Heat or Steam Sterilization

[03596010398147]

Moist Heat or Steam Sterilization

[03596010398147]

Moist Heat or Steam Sterilization

[03596010398147]

Moist Heat or Steam Sterilization

[03596010398147]

Moist Heat or Steam Sterilization

[03596010398147]

Moist Heat or Steam Sterilization

[03596010398147]

Moist Heat or Steam Sterilization

[03596010398147]

Moist Heat or Steam Sterilization

[03596010398147]

Moist Heat or Steam Sterilization

[03596010398147]

Moist Heat or Steam Sterilization

[03596010398147]

Moist Heat or Steam Sterilization

[03596010398147]

Moist Heat or Steam Sterilization

[03596010398147]

Moist Heat or Steam Sterilization

[03596010398147]

Moist Heat or Steam Sterilization

[03596010398147]

Moist Heat or Steam Sterilization

[03596010398147]

Moist Heat or Steam Sterilization

[03596010398147]

Moist Heat or Steam Sterilization

[03596010398147]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2021-10-11
• 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