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INDEPENDENCE MIS Spacers

by Globus Medical, Inc.

510(k) K160597

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 NumberK160597 Date29 Aug 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  • Withdrawn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
OVD
Device class
Class II
Regulation
21 CFR Part 888.3080
Advisory committee
Orthopedic
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

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

The Independence MIS Spacers are anterior lumbar interbody fusion devices designed to provide structural stability following discectomy in skeletally mature patients. These spacers are intended for use in minimally invasive spinal procedures, offering anchor fixation through a reduced surgical corridor. They are categorized under product code OVD and are classified as substantially equivalent under FDA 510(k) clearance (K160597). Available in various heights and geometric configurations, they are tailored to accommodate diverse anatomical requirements.

Independence MIS Spacers are supplied as reusable surgical instruments and are regulated under FDA 510(k) clearance (K160597) with a decision date of August 29, 2016. They are intended for use in orthopedic settings, specifically within the Orthopedic (OR) advisory committee category. No sterility or single-use specifications are explicitly stated in the provided data. The devices are designed for lumbar spine applications and must be handled according to standard surgical protocols.

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Questions

AI-generated answers, 1 Oct 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 Independence MIS Spacers designed for?

    Independence MIS Spacers are anterior lumbar interbody fusion devices intended to provide structural stability following discectomy in skeletally mature patients. They are specifically engineered for use in minimally invasive spinal procedures, allowing for anchor fixation through a smaller surgical corridor. This design helps reduce tissue trauma while maintaining stability during the fusion process.

  • How are Independence MIS Spacers supplied and what are their key features?

    Independence MIS Spacers are supplied as reusable surgical instruments. They come in various heights and geometric configurations to accommodate different anatomical requirements in the lumbar spine. The devices are categorized under product code OVD and are classified as substantially equivalent under FDA 510(k) clearance (K160597), ensuring compliance with regulatory standards for orthopedic applications.

  • Are Independence MIS Spacers single-use or reusable?

    The provided data does not explicitly specify whether Independence MIS Spacers are single-use or reusable. However, the description explicitly states they are supplied as reusable surgical instruments. Always follow manufacturer guidelines and institutional protocols for device handling and reprocessing to ensure safety and efficacy.

  • What regulatory pathway does Independence MIS Spacers follow?

    Independence MIS Spacers are regulated under the FDA 510(k) clearance pathway, specifically classified as substantially equivalent (SESE) with clearance number K160597. The decision was made by the Orthopedic (OR) advisory committee on August 29, 2016, ensuring they meet established standards for orthopedic devices in spinal fusion procedures.

  • Are there specific storage requirements for Independence MIS Spacers?

    While the provided data does not detail specific storage instructions, Independence MIS Spacers, like all surgical instruments, should be stored in a clean, dry environment to prevent contamination or damage. Follow standard surgical protocols for handling and storage to maintain their integrity and functionality for future use.