OSTEOPAL® 5130982

GUDID 04260102139428

OSTEOPAL® V is a standard-setting, low-viscosity, radiopaque, poly(methyl methacrylate)-based (PMMA) bone cement. It contains the X-ray contrast medium zirconium dioxide. To improve visibility in the surgical field, it has been colored with chlorophyll-copper-complex (E141). The bone cement consists of two components and is prepared immediately before use by mixing the polymer powder with the monomer liquid. The low viscosity increases with progressing polymerization. A paste forms that is inserted into the vertebral body using an application system and sets within a few minutes. OSTEOPAL® V is intended for single use and is supplied sterile.

Heraeus Medical GmbH

Orthopaedic cement, non-antimicrobial

• Primary Device ID: 04260102139428
• NIH Device Record Key: e5ec2d43-796b-4aa1-b62a-5be03d19ce12
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OSTEOPAL®
• Version Model Number: V
• Catalog Number: 5130982
• Company DUNS: 333623937
• Company Name: Heraeus Medical GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• 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	04260102139411 [Primary]
GS1	04260102139428 [Package]; Contains: 04260102139411; Package: Carton [20 Units]; In Commercial Distribution
GS1	04260102139435 [Package]; Package: Pallet [400 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K241674

FDA Product Code

• LOD: Bone Cement

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: 2025-10-06
• Device Publish Date: 2025-09-26

On-Brand Devices [OSTEOPAL®]

• 04260102132603: OSTEOPAL® plus is a radiopaque, low-viscosity bone cement, based on polymethyl methacrylate wit
• 04260102130326: Osteopal® V is an acrylic cement for use in vertebroplasty and kyphoplasty. It is formed from p
• 04260102139428: OSTEOPAL® V is a standard-setting, low-viscosity, radiopaque, poly(methyl methacrylate)-based (