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GPS Spacers

by G Surgical, LLC United States 510(k)

510(k) K142456 Product code ODP

Overview

GPS Spacers are intervertebral body fusion devices. They are substantially equivalent to predicate devices cleared for orthopedic use.

GPS Spacers are supplied by G Surgical, LLC and have received FDA 510(k) clearance under product code ODP. The device is intended for use in spinal fusion procedures.

Summary written by AI from registry data, 6 Oct 2026.Not verified

About this summary

This description and any FAQs on this page were generated automatically and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK142456 Date10 Apr 2015ClearedStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Recalls: none on record (FDA, checked 22 Oct 2026)

Specification

510(k) · synced 22 Oct 2026

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

Other devices from G Surgical LLC

See all devices from G Surgical LLC →

Questions

  • What is the intended use of GPS Spacers?

    GPS Spacers are intervertebral body fusion devices intended for use in spinal fusion procedures, as they are substantially equivalent to predicate devices cleared for orthopedic use under FDA 510(k) clearance K142456.

  • How are GPS Spacers supplied and by whom?

    GPS Spacers are supplied by G Surgical, LLC, located at 5757 Central Ave., Suite G, Boulder, CO 80301, and have received FDA 510(k) clearance under product code ODP.

  • What regulatory pathway was used for GPS Spacers?

    GPS Spacers received FDA 510(k) clearance through a traditional submission process, with decision code SESE and clearance date of April 10, 2015, confirming substantial equivalence to predicate devices.

Properties & raw data

Show properties, registry sources and raw records

Sources (1)

  • FDA 510(k) K142456 24 fields · synced 22 Oct 2026