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FDA 510(k)

INTEGRATE -C Interbody Fusion System

K-Number: K222004 · 2023-04-28

ApplicantHappe Spine
Decision Date2023-04-28
Product CodeODP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

INTEGRATE -C Interbody Fusion System is a medical device manufactured by Happe Spine. It received FDA 510(k) clearance on 2023-04-28 under approval number K222004. 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 INTEGRATE -C Interbody Fusion System?

INTEGRATE -C Interbody Fusion System is a medical device that received FDA 510(k) clearance on 2023-04-28. It is manufactured by Happe Spine. The 510(k) number is K222004.

When was INTEGRATE -C Interbody Fusion System approved by the FDA?

INTEGRATE -C Interbody Fusion System received FDA 510(k) clearance on 2023-04-28, under approval number K222004.

What company makes INTEGRATE -C Interbody Fusion System?

INTEGRATE -C Interbody Fusion System is manufactured by Happe Spine.

What is the FDA product code for INTEGRATE -C Interbody Fusion System?

The FDA product code for INTEGRATE -C Interbody Fusion System is ODP.

Related Clinical Trials

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT06462729 LDGraft in Single Level Anterior Lumbar Interbody Fusion (ALIF) RECRUITING NCT05438719 MOTUS Total Joint Replacement Investigational Device Exemption Study ACTIVE_NOT_RECRUITING NCT04823858 3Spine Lumbar Fusion Real World Evidence Study ACTIVE_NOT_RECRUITING NCT05762055 Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology ENROLLING_BY_INVITATION NCT03681262 Comparing Long-term Effectiveness of High Frequency and Burst Spinal Cord Stimulation ACTIVE_NOT_RECRUITING

Related PubMed Literature

PMID: 41608759 Collaborative and Cooperative Hospital "In-House" Medical Device Development and Implementation in the AI Age: The European Responsible AI Development (EURAID) Framework Compatible With European Values. Journal of medical Internet research (2026) PMID: 41166829 Assessment of intra-operative impact durability of additively manufactured mock lumbar intervertebral body fusion devices. Journal of biomechanics (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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