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FDA 510(k)

Altus Spine Sochi OCT Spinal System

K-Number: K210887 · 2021-08-20

ApplicantAltus Partners, LLC
Decision Date2021-08-20
Product CodeNKG
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Altus Spine Sochi OCT Spinal System is a medical device manufactured by Altus Partners, LLC. It received FDA 510(k) clearance on 2021-08-20 under approval number K210887. The device is classified under product code NKG. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Altus Spine Sochi OCT Spinal System?

Altus Spine Sochi OCT Spinal System is a medical device that received FDA 510(k) clearance on 2021-08-20. It is manufactured by Altus Partners, LLC. The 510(k) number is K210887.

When was Altus Spine Sochi OCT Spinal System approved by the FDA?

Altus Spine Sochi OCT Spinal System received FDA 510(k) clearance on 2021-08-20, under approval number K210887.

What company makes Altus Spine Sochi OCT Spinal System?

Altus Spine Sochi OCT Spinal System is manufactured by Altus Partners, LLC.

What is the FDA product code for Altus Spine Sochi OCT Spinal System?

The FDA product code for Altus Spine Sochi OCT Spinal System is NKG.

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Related PubMed Literature

PMID: 39973146 Characterization of Spine Implant Device Recalls: A 21-Year Analysis. Spine (2026) PMID: 37504879 Comparative Evaluation of Mineralized Bone Allografts for Spinal Fusion Surgery. Journal of functional biomaterials (2023) PMID: 36074993 Reported Events Associated With Spine Robots: An Analysis of the Food and Drug Administration's Manufacturer and User Facility Device Experience Database. Global spine journal (2023) PMID: 35685299 Multicenter, Double-Blinded, Randomized, Active-Sham Controlled Clinical Study Design to Assess the Safety and Effectiveness of a Novel High Frequency Electric Nerve Block System in the Treatment of Post-Amputation Pain (The QUEST Study). Journal of pain research (2022)

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: NKG)

K161032neon3™ universal OCT spinal stabilizationUlrich GmbH & Co. KG K162300Reform® POCT SystemPrecision Spine, Inc. K162136CastleLoc-S Posterior Cervical Fixation System; LnK Posterior Cervical Fixation SystemL&K BIOMED Co., Ltd. K161591QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc. K161478Xenco Medical Posterior Cervical SystemXenco Medical, LLC K161498Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, 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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