SPINAL HOOK SYSTEM™

GUDID 08800037556899

U&I CORPORATION

Spinal implant trial

• Primary Device ID: 08800037556899
• NIH Device Record Key: 15ae2dc3-0066-4723-9fd1-e8e9d4c8c926
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SPINAL HOOK SYSTEM™
• Version Model Number: SH0804-A1
• Company DUNS: 688811082
• Company Name: U&I CORPORATION
• Device Count: 1
• DM Exempt: true
• 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800037556899 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K031595

FDA Product Code

• KWP: APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Sterilization

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

[08800037556899]

Moist Heat or Steam Sterilization

[08800037556899]

Moist Heat or Steam Sterilization

[08800037556899]

Moist Heat or Steam Sterilization

[08800037556899]

Moist Heat or Steam Sterilization

[08800037556899]

Moist Heat or Steam Sterilization

[08800037556899]

Moist Heat or Steam Sterilization

[08800037556899]

Moist Heat or Steam Sterilization

[08800037556899]

Moist Heat or Steam Sterilization

[08800037556899]

Moist Heat or Steam Sterilization

[08800037556899]

Moist Heat or Steam Sterilization

[08800037556899]

Moist Heat or Steam Sterilization

[08800037556899]

Moist Heat or Steam Sterilization

[08800037556899]

Moist Heat or Steam Sterilization

[08800037556899]

Moist Heat or Steam Sterilization

[08800037556899]

Moist Heat or Steam Sterilization

[08800037556899]

Moist Heat or Steam Sterilization

[08800037556899]

Moist Heat or Steam Sterilization

[08800037556899]

Moist Heat or Steam Sterilization

[08800037556899]

Moist Heat or Steam Sterilization

[08800037556899]

Moist Heat or Steam Sterilization

[08800037556899]

Moist Heat or Steam Sterilization

[08800037556899]

Moist Heat or Steam Sterilization

[08800037556899]

Moist Heat or Steam Sterilization

[08800037556899]

Moist Heat or Steam Sterilization

[08800037556899]

Moist Heat or Steam Sterilization

[08800037556899]

Moist Heat or Steam Sterilization

[08800037556899]

Moist Heat or Steam Sterilization

[08800037556899]

Moist Heat or Steam Sterilization

[08800037556899]

Moist Heat or Steam Sterilization

[08800037556899]

Moist Heat or Steam Sterilization

[08800037556899]

Moist Heat or Steam Sterilization

[08800037556899]

Moist Heat or Steam Sterilization

[08800037556899]

Moist Heat or Steam Sterilization

[08800037556899]

Moist Heat or Steam Sterilization

[08800037556899]

Moist Heat or Steam Sterilization

[08800037556899]

Moist Heat or Steam Sterilization

[08800037556899]

Moist Heat or Steam Sterilization

[08800037556899]

Moist Heat or Steam Sterilization

[08800037556899]

Moist Heat or Steam Sterilization

[08800037556899]

Moist Heat or Steam Sterilization

[08800037556899]

Moist Heat or Steam Sterilization

[08800037556899]

Moist Heat or Steam Sterilization

[08800037556899]

Moist Heat or Steam Sterilization

[08800037556899]

Moist Heat or Steam Sterilization

[08800037556899]

Moist Heat or Steam Sterilization

[08800037556899]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-02-20
• Device Publish Date: 2023-02-12

On-Brand Devices [SPINAL HOOK SYSTEM™]

• 08800015941464: SH1960
• 08800015941457: SH0711-A6
• 08800015941440: SH0711-A5
• 08800015941433: SH0709-A8
• 08800015941426: SH0709-A7
• 08800015941419: SH0709-A2
• 08800015941402: SH0707-A7
• 08800015941396: SH0509-A2
• 08800015941372: SH0507-A3
• 08800015941365: SH0507-A2
• 08800015941358: SH0505-A2
• 08800015941341: SH0504-A2
• 08800015938334: SH0060
• 08800015938327: SH0050
• 08800015938310: SH0040
• 08800015938303: SH0032
• 08800015938297: SH0031
• 08800015938280: SH0030
• 08800015933070: SH1948
• 08800015933063: SH1940
• 08800015933056: SH1930
• 08800015933049: SH1920
• 08800015933032: SH0809-A1
• 08800015933025: SH0807-A1
• 08800015933018: SH0805-A1
• 08800015933001: SH0804-A1
• 08800015932998: SH0711-A2
• 08800015932981: SH0709-A6
• 08800015932974: SH0709-A5
• 08800015932967: SH0707-A2
• 08800015932950: SH0706-A2
• 08800015932943: SH0509-A4
• 08800015932936: SH0507-A4
• 08800015932929: SH0025
• 08800015932912: SH0024
• 08800037523150: SH0507-A7
• 08800037523143: SH0023
• 08800037523136: SH0022
• 08800037521200: SHS1051
• 08800037521194: SHS1050
• 08800037556929: SH0809-A1
• 08800037556912: SH0807-A1
• 08800037556905: SH0805-A1
• 08800037556899: SH0804-A1
• 08800037556400: SH0711-A2
• 08800037556394: SH0709-A8
• 08800037556387: SH0709-A7
• 08800037556370: SH0709-A2
• 08800037556363: SH0707-A7
• 08800037556356: SH0707-A2