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FDA 510(k)

Altus Spine HA Pedicle Screw System

K-Number: K200922 · 2021-01-26

ApplicantAltus Partners, LLC
Decision Date2021-01-26
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Altus Spine HA Pedicle Screw System is the device name listed in this FDA 510(k) record. The listed applicant is Altus Partners, LLC. It received FDA 510(k) clearance on 2021-01-26 under 510(k) number K200922. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Altus Spine HA Pedicle Screw System?

Altus Spine HA Pedicle Screw System is a medical device that received FDA 510(k) clearance on 2021-01-26. The listed applicant is Altus Partners, LLC. The 510(k) number is K200922.

When did Altus Spine HA Pedicle Screw System receive FDA 510(k) clearance?

Altus Spine HA Pedicle Screw System received FDA 510(k) clearance on 2021-01-26, under 510(k) number K200922.

Who is the listed applicant for Altus Spine HA Pedicle Screw System?

The FDA 510(k) record lists Altus Partners, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Altus Spine HA Pedicle Screw System?

The FDA product code for Altus Spine HA Pedicle Screw System is NKB.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT05565131Performance Measurement and Safety Evaluation of the PYTHEAS® ODYSSEE Angular Assistance System for Intra-pedicular Screw Placement in Adult Spine SurgeryCOMPLETED

Other records listing Altus Partners, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K243419Altus Spine Navigation SystemK211027Altus Spine Pedicle Screw SystemK211837Altus Spine Interbody Standalone Fusion SystemK210887Altus Spine Sochi OCT Spinal SystemK200322Altus Spine Pedicle Screw SystemK183084Fuji Cervical Plate System

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Related Devices (Code: NKB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260362QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS Configuration)MANTIZ Co., Ltd.K253943Tiger 2 SystemZavation Medical Products, LLCK261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.OK253045“Socko” Vimax Spinal Fixation SystemSocko Medical Co., Ltd.K251251ChanPin Pedicle Screw Spinal SystemChanpin Medtak Co., Ltd.

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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