TIMX 323005SS

GUDID 10705034241463

TIMX LOW BACK SYSTEM HEXLOBE SET SCREW M6 9.30mm

DEPUY SPINE, LLC

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 10705034241463
• NIH Device Record Key: 63da9242-2f35-4807-a2de-e71efb383973
• Commercial Distribution Discontinuation: 2019-12-31
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TIMX
• Version Model Number: 323005SS
• Catalog Number: 323005SS
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10705034241463 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K984348

FDA Product Code

• KWP: APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Sterilization

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

[10705034241463]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-12-12
• 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