Kyphon VuE™ Bone Cement

GUDID 08031497002538

TECRES SPA

Orthopaedic cement, non-antimicrobial

• Primary Device ID: 08031497002538
• NIH Device Record Key: da944ff8-4552-4147-aab8-5f532b0a17b9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Kyphon VuE™ Bone Cement
• Version Model Number: CT01A
• Company DUNS: 435428396
• Company Name: TECRES SPA
• 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: true
• 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	08031497002538 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K220131

FDA Product Code

• NDN: Cement, Bone, Vertebroplasty

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-05-23
• Device Publish Date: 2022-05-13

Devices Manufactured by TECRES SPA

• 08031497003894 - InterSpace Hip Trial, 46mm Short: 2026-02-19
• 08031497003900 - InterSpace Hip Trial, 54mm Short: 2026-02-19
• 08031497003917 - InterSpace Hip Trial, 60mm Short: 2026-02-19
• 08031497003924 - InterSpace Hip Trial, 46mm Long: 2026-02-19
• 08031497003931 - InterSpace Hip Trial, 54mm Long: 2026-02-19
• 08031497003948 - InterSpace Hip Trial, 60mm Long: 2026-02-19
• 08031497003955 - Interspace GV Hip Spacer 46: 2026-02-19 TAPERED WEDGE STEM
• 08031497003962 - Interspace GV Hip Spacer 54: 2026-02-19 TAPERED WEDGE STEM