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FDA 510(k)

The Integrity Spine Core System

K-Number: K223043 · 2023-03-20

ApplicantIntegrity Spine
Decision Date2023-03-20
Product CodeODP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

The Integrity Spine Core System is a medical device manufactured by Integrity Spine. It received FDA 510(k) clearance on 2023-03-20 under approval number K223043. The device is classified under product code ODP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the The Integrity Spine Core System?

The Integrity Spine Core System is a medical device that received FDA 510(k) clearance on 2023-03-20. It is manufactured by Integrity Spine. The 510(k) number is K223043.

When was The Integrity Spine Core System approved by the FDA?

The Integrity Spine Core System received FDA 510(k) clearance on 2023-03-20, under approval number K223043.

What company makes The Integrity Spine Core System?

The Integrity Spine Core System is manufactured by Integrity Spine.

What is the FDA product code for The Integrity Spine Core System?

The FDA product code for The Integrity Spine Core System is ODP.

Related Clinical Trials

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Related PubMed Literature

PMID: 42175114 Make Open Source Compliant: Validation in Non-Interventional Clinical Studies. Studies in health technology and informatics (2026)

Related Devices (Code: ODP)

K161127The Small PLATEAU (PLATEAU-C) Spacer SystemLife Spine, Inc. K162003IMSE Cervical CageThe Institute of Musculoskeletal Science & Education K160222OIC Cervical PEEK SpacerThe Orthopaedic Implant Company K161809ShurFit CpTi-HA ACIF Interbody Fusion SystemPrecision Spine, Inc. K162220DIO Medical IVA (ACIF, DLIF, PLIF, TLIF,and ALIF) CageDio Medical Co., Ltd. K161649Virtu C Spinal Implant SystemMet 1 Technologies, LLC

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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