TOWNLEY™ Transfacetpedicular Screw Fixation System

GUDID 00721902298462

UCS 4.0X24 CANN SCR TI

MEDTRONIC SOFAMOR DANEK, INC.

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

• Primary Device ID: 00721902298462
• NIH Device Record Key: 8976487e-bb7c-4ab4-b3a7-2a530d8a0e5b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TOWNLEY™ Transfacetpedicular Screw Fixation System
• Version Model Number: X873-024
• 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

• Outer Diameter: 4 Millimeter
• Outer Diameter: 4 Millimeter
• Outer Diameter: 4 Millimeter
• Outer Diameter: 4 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00721902298462 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K003928

FDA Product Code

• MRW: SYSTEM, FACET SCREW SPINAL DEVICE

Sterilization

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

[00721902298462]

Moist Heat or Steam Sterilization

[00721902298462]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-08-19

On-Brand Devices [TOWNLEY™ Transfacetpedicular Screw Fixation System]

• 00613994799623: SCREW X0410304 CORT NON-CANN TI 4.0X24
• 00613994799616: SCREW X0410303 CORT NON-CANN TI 4.0X22
• 00613994799609: SCREW X0410302 CORT NON-CANN TI 4.0X20
• 00613994799593: SCREW X0410173 CORT NON-CANN TI 3.5X18
• 00613994799586: SCREW X0410172 CORT NON-CANN TI 3.5X16
• 00613994799579: SCREW X0410171 CORT NON-CANN TI 3.5X14
• 00613994799562: SCREW X0410170 CORT NON-CANN TI 3.5X12
• 00613994799555: SCREW X0410169 CORT NON-CANN TI 3.5X10
• 00613994723277: SCREW X0509524 CORTICAL TI 3.5X28
• 00613994723260: SCREW X0509523 CORTICAL TI 3.5X26
• 00613994723253: SCREW X0509522 CORTICAL TI 3.5X24
• 00613994723246: SCREW X0509521 CORTICAL TI 3.5X22
• 00613994723239: SCREW X0509520 CORTICAL TI 3.5X20
• 00613994723222: SCREW X0509519 CORTICAL TI 3.5X18
• 00613994723215: SCREW X0509518 CORTICAL TI 3.5X16
• 00613994723208: SCREW X0509517 CORTICAL TI 3.5X14
• 00681490860574: UCS 4.0X32 CANN LAG SCR TI
• 00681490860567: UCS 4.0X30 X873-130 CANN LAG SCR TI
• 00681490860550: UCS 4.0X28 CANN LAG SCR TI
• 00681490860543: UCS 4.0X26 CANN LAG SCR TI
• 00681490860536: UCS 4.0X24 CANN LAG SCR TI
• 00681490833240: UCS 4.0X34 CANN LAG SCR TI
• 00721902298493: UCS 4.0X28 CANN SCR TI
• 00721902298479: UCS 4.0X26 CANN SCR TI
• 00721902298462: UCS 4.0X24 CANN SCR TI
• 00721902298455: UCS 4.0X22 CANN SCR TI
• 00721902298448: UCS 4.0X20 CANN SCR TI
• 00721902298431: UCS 4.0X18 CANN SCR TI
• 00721902043819: UCS 4.0X22 CANN LAG SCR TI
• 00721902043802: UCS 4.0X20 CANN LAG SCR TI
• 00721902043796: UCS 4.0X18 CANN LAG SCR TI