InterSpace Knee Trial XL

GUDID 08031497002903

InterSpace Knee Trial XL is intended to be used for the selection of the right size of InterSpace Knee XL to be implanted.

TECRES SPA

Knee revision prosthesis trial Knee revision prosthesis trial Knee revision prosthesis trial Knee revision prosthesis trial Knee revision prosthesis trial Knee revision prosthesis trial Knee revision prosthesis trial Knee revision prosthesis trial Knee revision prosthesis trial Knee revision prosthesis trial Knee revision prosthesis trial Knee revision prosthesis trial Knee revision prosthesis trial Knee revision prosthesis trial

• Primary Device ID: 08031497002903
• NIH Device Record Key: b7b2f751-3c21-444b-8ca2-8ada2db1da85
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: InterSpace Knee Trial XL
• Version Model Number: SPK03Z1
• Company DUNS: 435428396
• Company Name: TECRES SPA
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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	08031497002903 [Primary]

FDA Product Code

• HWT: Template

Sterilization

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

[08031497002903]

Moist Heat or Steam Sterilization

[08031497002903]

Moist Heat or Steam Sterilization

[08031497002903]

Moist Heat or Steam Sterilization

[08031497002903]

Moist Heat or Steam Sterilization

[08031497002903]

Moist Heat or Steam Sterilization

[08031497002903]

Moist Heat or Steam Sterilization

[08031497002903]

Moist Heat or Steam Sterilization

[08031497002903]

Moist Heat or Steam Sterilization

[08031497002903]

Moist Heat or Steam Sterilization

[08031497002903]

Moist Heat or Steam Sterilization

[08031497002903]

Moist Heat or Steam Sterilization

[08031497002903]

Moist Heat or Steam Sterilization

[08031497002903]

Moist Heat or Steam Sterilization

[08031497002903]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-10-03
• Device Publish Date: 2022-09-23

Devices Manufactured by TECRES SPA

• 08031497002057 - 2Mix Gun: 2024-02-20 2Mix Gun is designed to aid the extrusion of bone cement from 2Mix.
• 28031497001078 - 2Mix: 2024-02-20 2Mix is a medical device for mixing bone cement. The device includes several components: mixing container, mixing cap, cannula,
• 08031497003351 - TEKTONA HV US Bone Cement: 2023-06-16 TEKTONA HV US Bone Cement is indicated for the treatment of pathological fractures of the vertebral body using a vertebroplasty
• 08031497003313 - MENDEC SPINE HV: 2023-06-09 Mendec Spine HV is a highly viscous radiopaque acrylic resin (PMMA based) indicated for the treatment of pathological fractures
• 08031497002842 - MectaCem BonePrep: 2022-11-25
• 08031497002859 - MectaCem Bowl: 2022-11-25
• 08031497000695 - BONE INJECTION NEEDLE diamond tip 9 Gauge 150 mm length: 2022-10-03 BONE INJECTION NEEDLE diamond tip 9 Gauge 150 mm length with plastic handgrip intended for the injection of acrylic resin.
• 08031497000701 - BONE INJECTION NEEDLE diamond tip 11 Gauge 120 mm length: 2022-10-03 BONE INJECTION NEEDLE diamond tip 11 Gauge 120 mm length with plastic handgrip intended for the injection of acrylic resin.