TSRH® Spinal System

GUDID 00885074455600

SCREW 88936525 MAS 5.5MM ROD 6.5X25 TI

MEDTRONIC SOFAMOR DANEK, INC.

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 00885074455600
• NIH Device Record Key: 69af28b9-4e1d-48f1-9f3c-e415dff22bb9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TSRH® Spinal System
• Version Model Number: 88936525
• 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
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com

Device Dimensions

• Length: 25 Millimeter
• Length: 25 Millimeter
• Length: 25 Millimeter
• Length: 25 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 25 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 25 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 25 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 25 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 25 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 25 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 25 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 25 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 25 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 25 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 25 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 25 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 25 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 25 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 25 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 25 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 25 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00885074455600 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K052144

FDA Product Code

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

Sterilization

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

[00885074455600]

Moist Heat or Steam Sterilization

[00885074455600]

Moist Heat or Steam Sterilization

[00885074455600]

Moist Heat or Steam Sterilization

[00885074455600]

Moist Heat or Steam Sterilization

[00885074455600]

Moist Heat or Steam Sterilization

[00885074455600]

Moist Heat or Steam Sterilization

[00885074455600]

Moist Heat or Steam Sterilization

[00885074455600]

Moist Heat or Steam Sterilization

[00885074455600]

Moist Heat or Steam Sterilization

[00885074455600]

Moist Heat or Steam Sterilization

[00885074455600]

Moist Heat or Steam Sterilization

[00885074455600]

Moist Heat or Steam Sterilization

[00885074455600]

Moist Heat or Steam Sterilization

[00885074455600]

Moist Heat or Steam Sterilization

[00885074455600]

Moist Heat or Steam Sterilization

[00885074455600]

Moist Heat or Steam Sterilization

[00885074455600]

Moist Heat or Steam Sterilization

[00885074455600]

Moist Heat or Steam Sterilization

[00885074455600]

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: 2015-09-10

On-Brand Devices [TSRH® Spinal System]

• 00613994888518: SCREW X09103822 4.5X30 MPA LONG-POST
• 00613994888501: SCREW X09103823 4.5X35 MPA LONG-POST
• 00613994888495: SCREW X09103824 4.5X40 MPA LONG-POST
• 00613994888488: SCREW X09103825 4.5X45 MPA LONG-POST
• 00613994888471: SCREW X09103826 4.5X50 MPA LONG-POST
• 00613994888464: SCREW X09103827 4.5X55 MPA LONG-POST
• 00613994888457: SCREW X09103828 4.5X60 MPA LONG-POST
• 00613994888440: SCREW X09103829 4.5X30 MPA SHORT-POST
• 00613994888433: SCREW X09103830 4.5X35 MPA SHORT-POST
• 00613994888426: SCREW X09103831 4.5X40 MPA SHORT-POST
• 00613994888419: SCREW X09103832 4.5X45 MPA SHORT-POST
• 00613994888402: SCREW X09103833 4.5X50 MPA SHORT-POST
• 00613994888396: SCREW X09103834 4.5X55 MPA SHORT-POST
• 00613994888389: SCREW X09103835 4.5X60 MPA SHORT-POST
• 00613994888358: SCREW 83565359H TSRH OSTEOGRIP HA
• 00613994888341: SCREW 83565309H TSRH OSTEOGRIP HA
• 00613994888334: SCREW 83565259H TSRH OSTEOGRIP HA
• 00613994888327: SCREW 83565209H TSRH OSTEOGRIP HA
• 00613994888310: SCREW 83555609H TSRH OSTEOGRIP HA
• 00613994888303: SCREW 83555559H TSRH OSTEOGRIP HA
• 00613994888297: SCREW 83555509H TSRH OSTEOGRIP HA
• 00613994888280: SCREW 83555459H TSRH OSTEOGRIP HA
• 00613994888273: SCREW 83555409H TSRH OSTEOGRIP HA
• 00613994888266: SCREW 83555359H TSRH OSTEOGRIP HA
• 00613994888259: SCREW 83555309H TSRH OSTEOGRIP HA
• 00613994888242: SCREW 83555259H TSRH OSTEOGRIP HA
• 00613994888235: SCREW 83555209H TSRH OSTEOGRIP HA
• 00613994888228: SCREW 83545609H TSRH OSTEOGRIP HA
• 00613994888211: SCREW 83545559H TSRH OSTEOGRIP HA
• 00613994888204: SCREW 83545509H TSRH OSTEOGRIP HA
• 00613994888198: SCREW 83545459H TSRH OSTEOGRIP HA
• 00613994888181: SCREW 83545409H TSRH OSTEOGRIP HA
• 00613994888174: SCREW 83545359H TSRH OSTEOGRIP HA
• 00613994888167: SCREW 83545309H TSRH OSTEOGRIP HA
• 00613994888150: SCREW 83545259H TSRH OSTEOGRIP HA
• 00613994888143: SCREW 83545209H TSRH OSTEOGRIP HA
• 00613994888136: SCREW 83565409H TSRH OSTEOGRIP HA
• 00613994888129: SCREW 83585609H TSRH OSTEOGRIP HA
• 00613994888112: SCREW 83585559H TSRH OSTEOGRIP HA
• 00613994888105: SCREW 83585509H TSRH OSTEOGRIP HA
• 00613994888099: SCREW 83585459H TSRH OSTEOGRIP HA
• 00613994888082: SCREW 83585409H TSRH OSTEOGRIP HA
• 00613994888075: SCREW 83585359H TSRH OSTEOGRIP HA
• 00613994888068: SCREW 83585309H TSRH OSTEOGRIP HA
• 00613994888051: SCREW 83585259H TSRH OSTEOGRIP HA
• 00613994888044: SCREW 83585209H TSRH OSTEOGRIP HA
• 00613994888037: SCREW 83575609H TSRH OSTEOGRIP HA
• 00613994888020: SCREW 83575559H TSRH OSTEOGRIP HA
• 00613994888013: SCREW 83575509H TSRH OSTEOGRIP HA
• 00613994888006: SCREW 83575459H TSRH OSTEOGRIP HA