GDLH® Posterior Spinal System

GUDID 00673978130163

TSR TT T-BOLT 14MM 5.5 TI

MEDTRONIC SOFAMOR DANEK, INC.

Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 00673978130163
• NIH Device Record Key: fac50d43-474b-42d3-8c78-685c0f9f46f5
• Commercial Distribution Discontinuation: 2018-10-12
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: GDLH® Posterior Spinal System
• Version Model Number: X0196-034
• Company DUNS: 830350380
• Company Name: MEDTRONIC SOFAMOR DANEK, 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)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com

Device Dimensions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00673978130163 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K143375

FDA Product Code

• NKB: Orthosis, spinal pedicle fixation, for degenerative disc disease

Sterilization

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

[00673978130163]

Moist Heat or Steam Sterilization

[00673978130163]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-01-25
• Device Publish Date: 2016-03-16

On-Brand Devices [GDLH® Posterior Spinal System]

• 00673978130422: ROD 5.5X20CM HEX TI
• 00673978130415: ROD 5.5X18CM HEX SS
• 00673978130408: ROD 5.5X16CM HEX SS
• 00673978130392: ROD 5.5X14CM HEX TI
• 00673978130385: ROD 5.5X12CM HEX TI
• 00673978130361: ROD 5.5X9CM HEX TI
• 00673978130347: ROD 5.5X7CM HEX TI
• 00673978130316: ROD 5.5X4CM HEX TI
• 00673978130163: TSR TT T-BOLT 14MM 5.5 TI
• 00673978061825: ROD 855-011 5.5 MM HEX-END ROD L20 TI
• 00673978056258: ROD 845-011 5.5MM HEX END L20 51CM
• 00721902975233: ROD 5.5X30CM-TI-HEX
• 00721902975226: ROD 5.5X28CM-TI-HEX
• 00721902975219: ROD 5.5X26CM-TI-HEX
• 00721902975189: ROD 5.5X22CM-TI-HEX
• 00721902975158: ROD 5.5X11CM-TI-HEX