EBI ESL Spine Spacer System

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K040482 ↗

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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See all devices from Ebi, L.P. →

• What is the EBI ESL Spine Spacer System designed for?

  The EBI ESL Spine Spacer System is specifically designed for vertebral body replacement in the thoracolumbar spine. It preserves adjacent vertebral endplates to maintain structural integrity while providing a convex superior and inferior surface for conformance. The open transverse plane allows for effective bone graft packing and promotes bone growth, making it ideal for spinal reconstruction procedures where endplate preservation is critical.

• How is the EBI ESL Spine Spacer System supplied and what are its sterility and reuse guidelines?

  The EBI ESL Spine Spacer System is supplied as a sterile, single-use device. This ensures patient safety by preventing cross-contamination and maintaining sterility throughout the surgical procedure. Due to its single-use nature, it must not be reused after one surgical application, adhering to standard sterile device protocols for orthopedic implants.

• What regulatory approval does the EBI ESL Spine Spacer System hold?

  The EBI ESL Spine Spacer System holds FDA 510(k) clearance under the reference number K040482. This clearance indicates that the device is deemed substantially equivalent to a legally marketed predicate device, allowing it to be marketed in the United States for its intended use in spinal reconstruction.

• Are there any specific storage instructions for the EBI ESL Spine Spacer System?

  While detailed storage instructions are not provided beyond standard sterile device protocols, the system must be stored in a manner that preserves its sterility. This typically involves keeping it in its original packaging, in a clean, dry environment, and away from direct sunlight or extreme temperatures. Always follow manufacturer guidelines for sterile medical devices to ensure optimal performance and safety.

• Does the EBI ESL Spine Spacer System have any specific MRI safety classification?

  The available data does not specify an MRI safety classification for the EBI ESL Spine Spacer System. If MRI imaging is required post-surgery, clinicians should consult the manufacturer’s updated documentation or contact Ebi, L.P. for guidance on potential MRI compatibility, as this can vary based on material composition and surgical context.