Total Wrist Fusion System 303216

GUDID 00885556840009

2.7MM CORTICAL SCREW 16MM LONG

Smith & Nephew, Inc.

Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile

• Primary Device ID: 00885556840009
• NIH Device Record Key: 5a19fce8-9455-42c1-8db9-0b702841ebdc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Total Wrist Fusion System
• Version Model Number: 303216
• Catalog Number: 303216
• Company DUNS: 045483575
• 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: 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
• 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 Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00885556840009 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K093163

FDA Product Code

• LXT: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT, METAL COMPOSITE

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[00885556840009]

Moist Heat or Steam Sterilization

[00885556840009]

Moist Heat or Steam Sterilization

[00885556840009]

Moist Heat or Steam Sterilization

[00885556840009]

Moist Heat or Steam Sterilization

[00885556840009]

Moist Heat or Steam Sterilization

[00885556840009]

Moist Heat or Steam Sterilization

[00885556840009]

Moist Heat or Steam Sterilization

[00885556840009]

Moist Heat or Steam Sterilization

[00885556840009]

Moist Heat or Steam Sterilization

[00885556840009]

Moist Heat or Steam Sterilization

[00885556840009]

Moist Heat or Steam Sterilization

[00885556840009]

Moist Heat or Steam Sterilization

[00885556840009]

Moist Heat or Steam Sterilization

[00885556840009]

Moist Heat or Steam Sterilization

[00885556840009]

Moist Heat or Steam Sterilization

[00885556840009]

Moist Heat or Steam Sterilization

[00885556840009]

Moist Heat or Steam Sterilization

[00885556840009]

Moist Heat or Steam Sterilization

[00885556840009]

Moist Heat or Steam Sterilization

[00885556840009]

Moist Heat or Steam Sterilization

[00885556840009]

Moist Heat or Steam Sterilization

[00885556840009]

Moist Heat or Steam Sterilization

[00885556840009]

Moist Heat or Steam Sterilization

[00885556840009]

Moist Heat or Steam Sterilization

[00885556840009]

Moist Heat or Steam Sterilization

[00885556840009]

Moist Heat or Steam Sterilization

[00885556840009]

Moist Heat or Steam Sterilization

[00885556840009]

Moist Heat or Steam Sterilization

[00885556840009]

Moist Heat or Steam Sterilization

[00885556840009]

Moist Heat or Steam Sterilization

[00885556840009]

Moist Heat or Steam Sterilization

[00885556840009]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2023-09-07
• Device Publish Date: 2022-12-21

On-Brand Devices [Total Wrist Fusion System]

• 00885556840368: INSTRUMENT CASE COMPLETE - EMEA
• 00885556840306: INSTRUMENT CASE COMPLETE - US
• 00885556840269: PLATE BENDER - 3.5MM HOLE
• 00885556840252: PLATE BENDER - 2.7MM HOLE
• 00885556840245: 2.0MM SELF-RETAINING HEX DRIVER
• 00885556840238: 2.5MM SELF-RETAINING HEX DRIVER
• 00885556840221: SELF-RETAINING TORX DRIVER
• 00885556840214: DEPTH GAUGE
• 00885556840184: DOUBLE-ENDED GUIDE FOR 2.5MM CORTICAL DRILL BIT
• 00885556840177: DOUBLE-ENDED GUIDE FOR 2.0MM CORTICAL DRILL BIT
• 00885556840344: INSTRUMENT CASE LID (US/EMEA)
• 00885556840320: INSTRUMENT CASE TOP LEVEL (US/EMEA)
• 00885556840290: SHORT BEND PLATE TRIAL (EMEA SETS ONLY)
• 00885556840283: STANDARD BEND PLATE TRIAL (EMEA SETS ONLY)
• 00885556840276: STRAIGHT PLATE TRIAL (EMEA SETS ONLY)
• 00885556840542: 3.5MM CORTICAL SCREW 28MM LONG
• 00885556840535: 3.5MM CORTICAL SCREW 26MM LONG
• 00885556840528: 3.5MM CORTICAL SCREW 24MM LONG
• 00885556840511: 3.5MM CORTICAL SCREW 22MM LONG
• 00885556840504: 3.5MM CORTICAL SCREW 20MM LONG
• 00885556840498: 3.5MM CORTICAL SCREW 18MM LONG
• 00885556840481: 3.5MM CORTICAL SCREW 16MM LONG
• 00885556840474: 3.5MM CORTICAL SCREW 14MM LONG
• 00885556840467: 3.5MM CORTICAL SCREW 12MM LONG
• 00885556840450: 2.7MM CORTICAL SCREW 24MM LONG
• 00885556840443: 2.7MM CORTICAL SCREW 22MM LONG
• 00885556840436: 2.7MM CORTICAL SCREW 20MM LONG
• 00885556840429: 2.7MM CORTICAL SCREW 18MM LONG
• 00885556840412: 2.7MM CORTICAL SCREW 16MM LONG
• 00885556840405: 2.7MM CORTICAL SCREW 14MM LONG
• 00885556840399: 2.7MM CORTICAL SCREW 12MM LONG
• 00885556840382: 2.7MM CORTICAL SCREW 10MM LONG
• 00885556840375: INSTRUMENT CASE BASE (EMEA)
• 00885556840351: WRIST FUSION SCREW CADDY LID
• 00885556840337: INSTRUMENT CASE IMPLANT CADDY (US)
• 00885556840313: INSTRUMENT CASE BASE (US)
• 00885556840207: THREADED SURFIX DRILL GUIDE FOR 2.7MM DRILL BIT
• 00885556840191: THREADED SURFIX DRILL GUIDE FOR 2.0MM DRILL BIT
• 00885556840160: 2.7MM DRILL BIT
• 00885556840153: 2.5MM DRILL BIT
• 00885556840146: 2.0MM DRILL BIT
• 00885556840139: 3.5MM CORTICAL SCREW 28MM LONG
• 00885556840122: 3.5MM CORTICAL SCREW 26MM LONG
• 00885556840115: 3.5MM CORTICAL SCREW 24MM LONG
• 00885556840108: 3.5MM CORTICAL SCREW 22MM LONG
• 00885556840092: 3.5MM CORTICAL SCREW 20MM LONG
• 00885556840085: 3.5MM CORTICAL SCREW 18MM LONG
• 00885556840078: 3.5MM CORTICAL SCREW 16MM LONG
• 00885556840061: 3.5MM CORTICAL SCREW 14MM LONG
• 00885556840054: 3.5MM CORTICAL SCREW 12MM LONG