Interspace GV Hip Spacer 46

GUDID 08031497003955

TAPERED WEDGE STEM

TECRES SPA

Orthopaedic cement spacer

• Primary Device ID: 08031497003955
• NIH Device Record Key: 5b6e00e3-7406-47e0-8c29-bcfb3cdf64bd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Interspace GV Hip Spacer 46
• Version Model Number: IHGV46S
• 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: true
• 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 Dimensions

• Device Size Text, specify: 0
• Length: 96 Millimeter
• Device Size Text, specify: 0
• Length: 96 Millimeter
• Device Size Text, specify: 0
• Length: 96 Millimeter
• Device Size Text, specify: 0
• Length: 96 Millimeter
• Device Size Text, specify: 0
• Length: 96 Millimeter
• Device Size Text, specify: 0
• Length: 96 Millimeter
• Device Size Text, specify: 0
• Length: 96 Millimeter
• Device Size Text, specify: 0
• Length: 96 Millimeter
• Device Size Text, specify: 0
• Length: 96 Millimeter
• Device Size Text, specify: 0
• Length: 96 Millimeter
• Device Size Text, specify: 0
• Length: 96 Millimeter
• Device Size Text, specify: 0
• Length: 96 Millimeter
• Device Size Text, specify: 0
• Length: 96 Millimeter
• Device Size Text, specify: 0
• Length: 96 Millimeter
• Device Size Text, specify: 0
• Length: 96 Millimeter
• Device Size Text, specify: 0
• Length: 96 Millimeter
• Device Size Text, specify: 0
• Length: 96 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	08031497003955 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K252326

FDA Product Code

• KWL: Prosthesis, Hip, Hemi-, Femoral, Metal

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: 2026-02-19
• Device Publish Date: 2026-02-11

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: 2026-02-19TAPERED WEDGE STEM
• 08031497003955 - Interspace GV Hip Spacer 46: 2026-02-19 TAPERED WEDGE STEM
• 08031497003962 - Interspace GV Hip Spacer 54: 2026-02-19 TAPERED WEDGE STEM