71128150

GUDID 03596010590367

7.0MM X 150MM CANNULATED SCREW 32MM THREAD STAINLESS STEEL

Smith & Nephew, Inc.

Orthopaedic bone screw, non-bioabsorbable, sterile

• Primary Device ID: 03596010590367
• NIH Device Record Key: 5edfffd1-17a7-4026-bf29-5ad0679bdb41
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 71128150
• Catalog Number: 71128150
• 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: 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
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
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• Email: GUDID@SMITH-NEPHEW.COM
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• Email: GUDID@SMITH-NEPHEW.COM
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• Email: GUDID@SMITH-NEPHEW.COM
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• Email: GUDID@SMITH-NEPHEW.COM
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• 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
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• Phone: +1(800)238-7538
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• Phone: +1(800)238-7538
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• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
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• Phone: +1(800)238-7538
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• Phone: +1(800)238-7538
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• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
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• 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

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0
• Special Storage Condition, Specify: Between 0 and 0
• Special Storage Condition, Specify: Between 0 and 0
• Special Storage Condition, Specify: Between 0 and 0
• Special Storage Condition, Specify: Between 0 and 0
• Special Storage Condition, Specify: Between 0 and 0
• Special Storage Condition, Specify: Between 0 and 0
• Special Storage Condition, Specify: Between 0 and 0
• Special Storage Condition, Specify: Between 0 and 0
• Special Storage Condition, Specify: Between 0 and 0
• Special Storage Condition, Specify: Between 0 and 0
• Special Storage Condition, Specify: Between 0 and 0
• Special Storage Condition, Specify: Between 0 and 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	03596010590367 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210837
• Premarket Notification: K993106

FDA Product Code

• HRS: PLATE, FIXATION, BONE

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-10-22
• Device Publish Date: 2015-08-25

Devices Manufactured by Smith & Nephew, Inc.

• 00885556787786 - NA: 2026-03-02 SYNC GENERAL INSTRUMENTS MODULE
• 00885556884027 - NA: 2026-03-02 LM/RL PROXIMAL TIBIA CADDY
• 00885556884034 - NA: 2026-03-02 RM/LL PROXIMAL TIBIA CADDY
• 00885556884140 - NA: 2026-03-02 JOURNEY II UK SHORT TIBIA ALIGNMENT CADDY
• 00885556920947 - NA: 2026-03-02 KINEMATIC ALIGNMENT MODULE
• 00885556920954 - NA: 2026-03-02 SPIKED EM/IM AND ADJUSTABLE FEMUR MODULE
• 00885556917794 - EVOS: 2025-12-31 EVOS 3.5MM X 54MM CORTEX SCREW SELF-TAPPING
• 00885556915257 - NA: 2025-12-30 EM POSTERIOR SLOPE GUIDE SHORT