TIMX 325005SS

GUDID 10705034241470

TIMX LOW BACK SYSTEM SET SCREW-METRIC THREAD M7 9.30mm

DEPUY SPINE, LLC

Spinal bone set screw

• Primary Device ID: 10705034241470
• NIH Device Record Key: e117d4c2-b173-4ce8-a5a3-a0c3255da66e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TIMX
• Version Model Number: 325005SS
• Catalog Number: 325005SS
• Company DUNS: 107105876
• Company Name: DEPUY SPINE, LLC
• 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)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	10705034241470 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K953978

FDA Product Code

• KWQ: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Sterilization

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

[10705034241470]

Moist Heat or Steam Sterilization

[10705034241470]

Moist Heat or Steam Sterilization

[10705034241470]

Moist Heat or Steam Sterilization

[10705034241470]

Moist Heat or Steam Sterilization

[10705034241470]

Moist Heat or Steam Sterilization

[10705034241470]

Moist Heat or Steam Sterilization

[10705034241470]

Moist Heat or Steam Sterilization

[10705034241470]

Moist Heat or Steam Sterilization

[10705034241470]

Moist Heat or Steam Sterilization

[10705034241470]

Moist Heat or Steam Sterilization

[10705034241470]

Moist Heat or Steam Sterilization

[10705034241470]

Moist Heat or Steam Sterilization

[10705034241470]

Moist Heat or Steam Sterilization

[10705034241470]

Moist Heat or Steam Sterilization

[10705034241470]

Moist Heat or Steam Sterilization

[10705034241470]

Moist Heat or Steam Sterilization

[10705034241470]

Moist Heat or Steam Sterilization

[10705034241470]

Moist Heat or Steam Sterilization

[10705034241470]

Moist Heat or Steam Sterilization

[10705034241470]

Moist Heat or Steam Sterilization

[10705034241470]

Moist Heat or Steam Sterilization

[10705034241470]

Moist Heat or Steam Sterilization

[10705034241470]

Moist Heat or Steam Sterilization

[10705034241470]

Moist Heat or Steam Sterilization

[10705034241470]

Moist Heat or Steam Sterilization

[10705034241470]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2024-07-23
• Device Publish Date: 2015-09-24

On-Brand Devices [TIMX]

• 10705034008349: TIMX LOW BACK SYSTEM TORQUE WRENCH-SHAFT
• 10705034241463: TIMX LOW BACK SYSTEM HEXLOBE SET SCREW M6 9.30mm
• 10705034000596: TIMX LOW BACK SYSTEM HEXLOBE DRIVER
• 10705034241470: TIMX LOW BACK SYSTEM SET SCREW-METRIC THREAD M7 9.30mm