Velofix™ SA Cervical Cage

GUDID 08800015960779

U&I CORPORATION

Polymeric spinal interbody fusion cage

• Primary Device ID: 08800015960779
• NIH Device Record Key: f3fc7bfa-be79-4c2b-8342-cfdab7f01312
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Velofix™ SA Cervical Cage
• Version Model Number: TS3511FD
• 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	08800015960779 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172424

FDA Product Code

• OVE: Intervertebral fusion device with integrated fixation, cervical

Sterilization

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

[08800015960779]

Moist Heat or Steam Sterilization

[08800015960779]

Moist Heat or Steam Sterilization

[08800015960779]

Moist Heat or Steam Sterilization

[08800015960779]

Moist Heat or Steam Sterilization

[08800015960779]

Moist Heat or Steam Sterilization

[08800015960779]

Moist Heat or Steam Sterilization

[08800015960779]

Moist Heat or Steam Sterilization

[08800015960779]

Moist Heat or Steam Sterilization

[08800015960779]

Moist Heat or Steam Sterilization

[08800015960779]

Moist Heat or Steam Sterilization

[08800015960779]

Moist Heat or Steam Sterilization

[08800015960779]

Moist Heat or Steam Sterilization

[08800015960779]

Moist Heat or Steam Sterilization

[08800015960779]

Moist Heat or Steam Sterilization

[08800015960779]

Moist Heat or Steam Sterilization

[08800015960779]

Moist Heat or Steam Sterilization

[08800015960779]

Moist Heat or Steam Sterilization

[08800015960779]

Moist Heat or Steam Sterilization

[08800015960779]

Moist Heat or Steam Sterilization

[08800015960779]

Moist Heat or Steam Sterilization

[08800015960779]

Moist Heat or Steam Sterilization

[08800015960779]

Moist Heat or Steam Sterilization

[08800015960779]

Moist Heat or Steam Sterilization

[08800015960779]

Moist Heat or Steam Sterilization

[08800015960779]

Moist Heat or Steam Sterilization

[08800015960779]

Moist Heat or Steam Sterilization

[08800015960779]

Moist Heat or Steam Sterilization

[08800015960779]

Moist Heat or Steam Sterilization

[08800015960779]

Moist Heat or Steam Sterilization

[08800015960779]

Moist Heat or Steam Sterilization

[08800015960779]

Moist Heat or Steam Sterilization

[08800015960779]

Moist Heat or Steam Sterilization

[08800015960779]

Moist Heat or Steam Sterilization

[08800015960779]

Moist Heat or Steam Sterilization

[08800015960779]

Moist Heat or Steam Sterilization

[08800015960779]

Moist Heat or Steam Sterilization

[08800015960779]

Moist Heat or Steam Sterilization

[08800015960779]

Moist Heat or Steam Sterilization

[08800015960779]

Moist Heat or Steam Sterilization

[08800015960779]

Moist Heat or Steam Sterilization

[08800015960779]

Moist Heat or Steam Sterilization

[08800015960779]

Moist Heat or Steam Sterilization

[08800015960779]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-02-24
• Device Publish Date: 2018-06-23

On-Brand Devices [Velofix™ SA Cervical Cage]

• 08800015997386: TSS1001
• 08800015995511: TS0040
• 08800037504357: TS0050
• 08800037504340: TS0060
• 08800037507266: TSS1001
• 08800037507259: TS0100
• 08800037507242: TS0040
• 08800037508263: TS0130
• 08800037508256: TS0120
• 08800037508249: TS0110
• 08800037508232: TS0030
• 08800037508225: TS0020
• 08800037508218: TS0010
• 08800037521224: TS0070
• 08800037519771: TSA1000
• 08800015960991: RSA1000
• 08800015960984: TSA1000
• 08800015960977: TS4020FD
• 08800015960960: TS4019FD
• 08800015960953: TS4018FD
• 08800015960946: TS4017FD
• 08800015960939: TS4016FD
• 08800015960922: TS4015FD
• 08800015960915: TS4014FD
• 08800015960908: TS4013FD
• 08800015960892: TS4012FD
• 08800015960885: TS4011FD
• 08800015960878: TS4010FD
• 08800015960861: TS3520FD
• 08800015960854: TS3519FD
• 08800015960847: TS3518FD
• 08800015960830: TS3517FD
• 08800015960823: TS3516FD
• 08800015960816: TS3515FD
• 08800015960809: TS3514FD
• 08800015960793: TS3513FD
• 08800015960786: TS3512FD
• 08800015960779: TS3511FD
• 08800015960762: TS3510FD
• 08800015960755: TS4020FT
• 08800015960748: TS4019FT
• 08800015960731: TS4018FT
• 08800015960724: TS4017FT
• 08800015960717: TS4016FT
• 08800015960700: TS4015FT
• 08800015960694: TS4014FT
• 08800015960687: TS4013FT
• 08800015960670: TS4012FT
• 08800015960663: TS4011FT
• 08800015960656: TS4010FT