Global Spinal Fixation System™

GUDID 08800037557117

U&I CORPORATION

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 08800037557117
• NIH Device Record Key: f144de23-4400-4f1f-b73d-d1149dcedb2d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Global Spinal Fixation System™
• Version Model Number: SG6025
• 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	08800037557117 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K042928

FDA Product Code

• MNH: Orthosis, spondylolisthesis spinal fixation

Sterilization

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

[08800037557117]

Moist Heat or Steam Sterilization

[08800037557117]

Moist Heat or Steam Sterilization

[08800037557117]

Moist Heat or Steam Sterilization

[08800037557117]

Moist Heat or Steam Sterilization

[08800037557117]

Moist Heat or Steam Sterilization

[08800037557117]

Moist Heat or Steam Sterilization

[08800037557117]

Moist Heat or Steam Sterilization

[08800037557117]

Moist Heat or Steam Sterilization

[08800037557117]

Moist Heat or Steam Sterilization

[08800037557117]

Moist Heat or Steam Sterilization

[08800037557117]

Moist Heat or Steam Sterilization

[08800037557117]

Moist Heat or Steam Sterilization

[08800037557117]

Moist Heat or Steam Sterilization

[08800037557117]

Moist Heat or Steam Sterilization

[08800037557117]

Moist Heat or Steam Sterilization

[08800037557117]

Moist Heat or Steam Sterilization

[08800037557117]

Moist Heat or Steam Sterilization

[08800037557117]

Moist Heat or Steam Sterilization

[08800037557117]

Moist Heat or Steam Sterilization

[08800037557117]

Moist Heat or Steam Sterilization

[08800037557117]

Moist Heat or Steam Sterilization

[08800037557117]

Moist Heat or Steam Sterilization

[08800037557117]

Moist Heat or Steam Sterilization

[08800037557117]

Moist Heat or Steam Sterilization

[08800037557117]

Moist Heat or Steam Sterilization

[08800037557117]

Moist Heat or Steam Sterilization

[08800037557117]

Moist Heat or Steam Sterilization

[08800037557117]

Moist Heat or Steam Sterilization

[08800037557117]

Moist Heat or Steam Sterilization

[08800037557117]

Moist Heat or Steam Sterilization

[08800037557117]

Moist Heat or Steam Sterilization

[08800037557117]

Moist Heat or Steam Sterilization

[08800037557117]

Moist Heat or Steam Sterilization

[08800037557117]

Moist Heat or Steam Sterilization

[08800037557117]

Moist Heat or Steam Sterilization

[08800037557117]

Moist Heat or Steam Sterilization

[08800037557117]

Moist Heat or Steam Sterilization

[08800037557117]

Moist Heat or Steam Sterilization

[08800037557117]

Moist Heat or Steam Sterilization

[08800037557117]

Moist Heat or Steam Sterilization

[08800037557117]

Moist Heat or Steam Sterilization

[08800037557117]

Moist Heat or Steam Sterilization

[08800037557117]

Moist Heat or Steam Sterilization

[08800037557117]

Moist Heat or Steam Sterilization

[08800037557117]

Moist Heat or Steam Sterilization

[08800037557117]

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 [Global Spinal Fixation System™]

• 08800015946728: SG003-D
• 08800015946711: SG003-C
• 08800015946704: SG003-B
• 08800015946698: SG003-A
• 08800015946681: SG003
• 08800015946674: SG002-D
• 08800015946667: SG002-C
• 08800015946650: SG002-B
• 08800015946643: SG002-A
• 08800015946636: SG002
• 08800015946629: SG001-E
• 08800015946612: SG001-D
• 08800015946605: SG001-C
• 08800015946599: SG001-B
• 08800015946582: SG001-A
• 08800015946575: SG001
• 08800015946568: SGS1008
• 08800015946551: SGS1007
• 08800015946544: SGS1006
• 08800015946537: SGS1005
• 08800015946520: SGS1004
• 08800015946513: SGS1002
• 08800015946506: SGS1001
• 08800015946490: SG0043
• 08800015946483: SG0042
• 08800015946476: SG0041
• 08800015946469: SG0040
• 08800015946452: SG0038
• 08800015946445: SG0034
• 08800015946438: SG0033
• 08800015946421: SG0020
• 08800015946414: SG0019
• 08800015946407: SG0017
• 08800015946391: SG0016
• 08800015946384: SG0015
• 08800015946377: SG0014
• 08800015946360: SG0013
• 08800015946353: SG0010
• 08800015946346: SG0009
• 08800015946339: SG0003
• 08800015946322: SG0002
• 08800015941310: SG2200
• 08800015941303: SG2180
• 08800015941297: SG2170
• 08800015941280: SG2160
• 08800015941273: SG2150
• 08800015941266: SG2140
• 08800015935364: SGA2460S
• 08800015935357: SGA2120
• 08800015935340: SGA2110