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SUSTAIN Additional Implants

by Globus Medical, Inc.

510(k) K151665

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK151665 Date16 Mar 2016ClearedStatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

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

Overview

AI-generated summary, 22 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

Sustain Additional Implants are posterior interbody spacers designed for use in orthopedic procedures. These devices are manufactured from radiolucent polyetheretherketone (PEEK) and are available with a titanium plasma spray coating to provide a titanium interface.

The implants feature rounded corners and a grip-style connection to facilitate control during insertion and positioning. This device received FDA 510(k) clearance under K151665.

Other devices from Globus Medical, Inc.

See all devices from Globus Medical, Inc. →

Questions

AI-generated answers, 22 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What are SUSTAIN Additional Implants used for?

    These devices are posterior interbody spacers intended for use in orthopedic surgical procedures to provide structural support within the intervertebral space.

  • What materials are used to manufacture these implants?

    The implants are constructed from radiolucent polyetheretherketone (PEEK). They are also available with a titanium plasma spray coating, which creates a titanium interface for the device.

  • How is the insertion of these implants controlled?

    The implants are designed with rounded corners and a grip-style connection. This specific design facilitates greater control for the surgeon during the insertion and positioning phases of the procedure.

  • What is the regulatory status of the SUSTAIN Additional Implants?

    The SUSTAIN Additional Implants received FDA 510(k) clearance under K151665, having been determined to be substantially equivalent to existing devices.