IDYS-C® ZP 3DTi 44582409-S

GUDID 03700780635917

WEDGE CERVICAL CAGE

CLARIANCE

Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage

• Primary Device ID: 03700780635917
• NIH Device Record Key: 527a7a2e-2d52-423e-a37c-9fd2f98483ba
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IDYS-C® ZP 3DTi
• Version Model Number: 44582409-S
• Catalog Number: 44582409-S
• Company DUNS: 296568400
• Company Name: CLARIANCE
• 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: true
• Manufacturing Date: true
• Expiration Date: true
• 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: +1 773 868 7041
• Email: s.chambat@clariance-spine.us
• Phone: +1 773 868 7041
• Email: s.chambat@clariance-spine.us
• Phone: +1 773 868 7041
• Email: s.chambat@clariance-spine.us
• Phone: +1 773 868 7041
• Email: s.chambat@clariance-spine.us
• Phone: +1 773 868 7041
• Email: s.chambat@clariance-spine.us
• Phone: +1 773 868 7041
• Email: s.chambat@clariance-spine.us
• Phone: +1 773 868 7041
• Email: s.chambat@clariance-spine.us
• Phone: +1 773 868 7041
• Email: s.chambat@clariance-spine.us
• Phone: +1 773 868 7041
• Email: s.chambat@clariance-spine.us
• Phone: +1 773 868 7041
• Email: s.chambat@clariance-spine.us
• Phone: +1 773 868 7041
• Email: s.chambat@clariance-spine.us
• Phone: +1 773 868 7041
• Email: s.chambat@clariance-spine.us
• Phone: +1 773 868 7041
• Email: s.chambat@clariance-spine.us
• Phone: +1 773 868 7041
• Email: s.chambat@clariance-spine.us
• Phone: +1 773 868 7041
• Email: s.chambat@clariance-spine.us

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	03700780635917 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K212562

FDA Product Code

• ODP: Intervertebral fusion device with bone graft, cervical

Sterilization

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

[03700780635917]

Radiation Sterilization

[03700780635917]

Radiation Sterilization

[03700780635917]

Radiation Sterilization

[03700780635917]

Radiation Sterilization

[03700780635917]

Radiation Sterilization

[03700780635917]

Radiation Sterilization

[03700780635917]

Radiation Sterilization

[03700780635917]

Radiation Sterilization

[03700780635917]

Radiation Sterilization

[03700780635917]

Radiation Sterilization

[03700780635917]

Radiation Sterilization

[03700780635917]

Radiation Sterilization

[03700780635917]

Radiation Sterilization

[03700780635917]

Radiation Sterilization

[03700780635917]

Radiation Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-12-14
• Device Publish Date: 2021-12-06

On-Brand Devices [IDYS-C® ZP 3DTi]

• 03700780635962: WEDGE CERVICAL CAGE
• 03700780635955: WEDGE CERVICAL CAGE
• 03700780635948: WEDGE CERVICAL CAGE
• 03700780635924: WEDGE CERVICAL CAGE
• 03700780635917: WEDGE CERVICAL CAGE
• 03700780635900: WEDGE CERVICAL CAGE
• 03700780635894: WEDGE CERVICAL CAGE
• 03700780635887: WEDGE CERVICAL CAGE
• 03700780635863: WEDGE CERVICAL CAGE
• 03700780635856: WEDGE CERVICAL CAGE
• 03700780635849: WEDGE CERVICAL CAGE
• 03700780635832: WEDGE CERVICAL CAGE
• 03700780635825: WEDGE CERVICAL CAGE
• 03700780635801: WEDGE CERVICAL CAGE
• 03700780635795: ANATOMIC CERVICAL CAGE
• 03700780635788: ANATOMIC CERVICAL CAGE
• 03700780635771: ANATOMIC CERVICAL CAGE
• 03700780635764: ANATOMIC CERVICAL CAGE
• 03700780635740: SECURE ANATOMIC CAGE
• 03700780635733: ANATOMIC CERVICAL CAGE
• 03700780635726: ANATOMIC CERVICAL CAGE
• 03700780635719: ANATOMIC CERVICAL CAGE
• 03700780635702: ANATOMIC CERVICAL CAGE
• 03700780635689: ANATOMIC CERVICAL CAGE
• 03700780635672: ANATOMIC CERVICAL CAGE
• 03700780635665: ANATOMIC CERVICAL CAGE
• 03700780635658: ANATOMIC CERVICAL CAGE
• 03700780635641: ANATOMIC CERVICAL CAGE
• 03700780635627: ANATOMIC CERVIVAL CAGE