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FDA 510(k)

Altus Spine Cervical Interbody Fusion System

K-Number: K172253 · 2017-11-21

ApplicantAltus Partners, LLC
Decision Date2017-11-21
Product CodeODP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Altus Spine Cervical Interbody Fusion System is a medical device manufactured by Altus Partners, LLC. It received FDA 510(k) clearance on 2017-11-21 under approval number K172253. 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 Altus Spine Cervical Interbody Fusion System?

Altus Spine Cervical Interbody Fusion System is a medical device that received FDA 510(k) clearance on 2017-11-21. It is manufactured by Altus Partners, LLC. The 510(k) number is K172253.

When was Altus Spine Cervical Interbody Fusion System approved by the FDA?

Altus Spine Cervical Interbody Fusion System received FDA 510(k) clearance on 2017-11-21, under approval number K172253.

What company makes Altus Spine Cervical Interbody Fusion System?

Altus Spine Cervical Interbody Fusion System is manufactured by Altus Partners, LLC.

What is the FDA product code for Altus Spine Cervical Interbody Fusion System?

The FDA product code for Altus Spine Cervical 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 NCT07606729 AI-Driven Programs for Non-specific Chronic Neck Pain ACTIVE_NOT_RECRUITING NCT07606196 The Effect of Otolith Dysfunction and Its Rehabilitation in Vestibular Diseases COMPLETED NCT05438719 MOTUS Total Joint Replacement Investigational Device Exemption Study ACTIVE_NOT_RECRUITING NCT04823858 3Spine Lumbar Fusion Real World Evidence Study ACTIVE_NOT_RECRUITING

Related PubMed Literature

PMID: 41839575 A Perspective for Integrating Real-World Evidence Into the Investigational Device Exemption Study Design for Lumbar Total Joint Replacement. International journal of spine surgery (2026) PMID: 41166829 Assessment of intra-operative impact durability of additively manufactured mock lumbar intervertebral body fusion devices. Journal of biomechanics (2026)

Other Devices by Altus Partners, LLC

K170553Altus Spine Interbody Fusion System K171329Altus Spine Titanium Interbody Fusion System K170512Altus Spine Titanium Interbody Fusion System K163061Altus Spine Cervical Plate System K160976Altus Spine Interbody Fusion System K181339Altus Spine Pedicle Screw System

View all 16 devices →

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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