Vertebral Body Replacement (K003155)

No FDA recalls found in the data synced 22 Oct 2026.

Full name

Vertebral Body Replacement

510(k) Number

K003155 ↗

FDA Product Code

MQP

Device Class

Class II

Regulation

21 CFR Part 888.3060

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

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• Osteotech Musculoskeletal Tissue Recovery Pack

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  FDA 510(k) K951811 Active Cleared 31 May 1995

See all devices from Osteotech, Inc. →

• What is the Osteotech K003155 Vertebral Body Replacement used for?

  The Osteotech K003155 Vertebral Body Replacement is an implantable device intended to replace damaged or diseased vertebral bodies in the spine. It is specifically designed to restore structural integrity and spinal alignment during orthopedic surgical procedures, addressing conditions where vertebral body substitution is required.

• Is the Osteotech K003155 Vertebral Body Replacement sterile and single-use?

  Yes, the Osteotech K003155 Vertebral Body Replacement is supplied as a sterile, single-use implant. This ensures safety and compliance with surgical standards, preventing contamination and maintaining integrity before use in procedures.

• How is the Osteotech K003155 Vertebral Body Replacement regulated?

  The device is regulated under the FDA’s 510(k) clearance process, classified under product code MQP. It follows a traditional review pathway with advisory committee classification in orthopedics, ensuring it meets regulatory standards for spinal implants.

• What storage and handling precautions must be followed for the Osteotech K003155?

  Storage and handling must adhere to standard surgical implant protocols to preserve sterility and structural integrity. This includes maintaining proper packaging until immediate preoperative use, avoiding contamination, and following manufacturer guidelines for shelf life.

• Does the Osteotech K003155 Vertebral Body Replacement have any specific MRI safety information?

  The provided data does not include specific MRI safety information for the Osteotech K003155 Vertebral Body Replacement. Clinicians should verify compatibility with MRI systems and protocols prior to use, as some implants may pose risks in magnetic fields.