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FDA 510(k)

Altus Spine Interbody Standalone Fusion System

K-Number: K211837 · 2022-04-19

ApplicantAltus Partners, LLC
Decision Date2022-04-19
Product CodeOVD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Altus Spine Interbody Standalone Fusion System is a medical device manufactured by Altus Partners, LLC. It received FDA 510(k) clearance on 2022-04-19 under approval number K211837. The device is classified under product code OVD. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Altus Spine Interbody Standalone Fusion System?

Altus Spine Interbody Standalone Fusion System is a medical device that received FDA 510(k) clearance on 2022-04-19. It is manufactured by Altus Partners, LLC. The 510(k) number is K211837.

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

Altus Spine Interbody Standalone Fusion System received FDA 510(k) clearance on 2022-04-19, under approval number K211837.

What company makes Altus Spine Interbody Standalone Fusion System?

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

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

The FDA product code for Altus Spine Interbody Standalone Fusion System is OVD.

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 NCT07589023 A Retrospective Review: Outcomes of the REFLECT™ System for Idiopathic Scoliosis NOT_YET_RECRUITING NCT05762055 Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology ENROLLING_BY_INVITATION

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 K172253Altus Spine Cervical 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

View all 16 devices →

Related Devices (Code: OVD)

K162680SOVEREIGN® Spinal SystemMedtronic Sofamor Danek USA, Inc. K162351SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion DeviceSeaSpine Orthopedics Corporation K161993Leva® Anterior Interbody SystemSpine Wave, Inc. K161379ELSA SpacersGlobus Medical, Inc. K161173Avenue® T TLIF CageLdr Spine USA, Inc. K161129PILLAR SA PTCOrthofix, Inc.

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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