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Falcon Spacer

by Synthes (USA) Products, LLC 510(k)

Active United States

510(k) K123180

Overview

The Falcon Spacer is a radiolucent, oval-shaped interbody fusion device designed for use during spinal surgery to treat degenerative disc disease. It features pyramidal teeth on its superior and inferior surfaces to provide stabilization and an open architecture that allows for packing with autogenous bone graft.

This device requires supplemental fixation for use and is subject to FDA 510(k) authorization. It is categorized under the orthopedic advisory committee and is identified by the product code MAX.

AI-generated from registry data, 26 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK123180 Date8 Jan 2013ClearedStatusActive

Coverage

1 jurisdiction

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  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
MAX
Device Class
Class II
Regulation
21 CFR Part 888.3080
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

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Questions

  • What is the primary clinical application for the Falcon Spacer?

    The Falcon Spacer is indicated for use during spinal surgery to treat degenerative disc disease. It is designed as an interbody fusion device to provide stabilization through its pyramidal teeth on the superior and inferior surfaces.

  • Does the Falcon Spacer require additional support during surgery?

    Yes, this device requires supplemental fixation to be used effectively. It is designed to work in conjunction with other stabilization methods to ensure proper spinal support.

  • How is the Falcon Spacer designed to support bone growth?

    The device features an open architecture design. This structure allows the surgeon to pack the spacer with autogenous bone graft, which facilitates the fusion process during the treatment of degenerative disc disease.

  • What is the regulatory status of the Falcon Spacer?

    The Falcon Spacer is subject to FDA 510(k) authorization, identified by the k-number K123180. It has been determined to be substantially equivalent to other devices under the orthopedic advisory committee, categorized by product code MAX.