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Data / Medical devices / United States / Altus Partners

Altus Partners: FDA-registered device maker in West Chester, PA, United States, 20 510(k) clearances

Altus Partners is registered with the FDA (registration 3009049161) in West Chester, PA, United States. It lists 10 device types. The FDA files 20 510(k) clearances under its listings, the newest dated May 8, 2025. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this oneWatch Altus Partners
FDA registration number
3009049161
Address
1340 Enterprise DR, West Chester, PA, United States, 19380
Owner or operator
Altus Partners (10035934)
Roles
Repackager or relabeler, Specification developer
First device listed
April 5, 2011
Registered through
2026
Brand names listed
4.5 Fuji Screw, Altus Spine Cervical Interbody Fusion System, Altus Spine Cervical Plate System, Altus Spine HA Pedicle Screw System, Altus Spine Interbody Standalone Fusion System, Altus Spine Navigation System, Altus Spine Pedicle Screw System, Altus Spine Sochi Oct Spinal System and more

Devices it lists

DeviceProduct codeClassRoleSource
Appliance, Fixation, Spinal InterlaminalKWP2Repackager or relabeler, Specification developeraccessdata.fda.gov
Appliance, Fixation, Spinal Intervertebral BodyKWQ2Repackager or relabeler, Specification developeraccessdata.fda.gov
Intervertebral Fusion Device With Bone Graft, CervicalODP2Specification developeraccessdata.fda.gov
Intervertebral Fusion Device With Bone Graft, LumbarMAX2Repackager or relabeler, Specification developeraccessdata.fda.gov
Intervertebral Fusion Device With Integrated Fixation, LumbarOVD2Specification developeraccessdata.fda.gov
Orthopedic Stereotaxic InstrumentOLO2Specification developeraccessdata.fda.gov
Orthosis, Spinal Pedicle FixationMNI2Specification developeraccessdata.fda.gov
Orthosis, Spondylolisthesis Spinal FixationMNH2Specification developeraccessdata.fda.gov
Posterior Cervical Screw SystemNKG2Repackager or relabeler, Specification developeraccessdata.fda.gov
Thoracolumbosacral Pedicle Screw SystemNKB2Specification developeraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
May 8, 2025K243419Altus Spine Navigation SystemOLOSubstantially EquivalentAltus Partners, LLCaccessdata.fda.gov
April 19, 2023K230766Altus Spine Monaco Pedicle Screw SystemNKBSubstantially EquivalentAltus Spineaccessdata.fda.gov
September 16, 2022K211027Altus Spine Pedicle Screw SystemNKBSubstantially EquivalentAltus Partners, LLCaccessdata.fda.gov
April 19, 2022K211837Altus Spine Interbody Standalone Fusion SystemOVDSubstantially EquivalentAltus Partners, LLCaccessdata.fda.gov
August 20, 2021K210887Altus Spine Sochi OCT Spinal SystemNKGSubstantially EquivalentAltus Partners, LLCaccessdata.fda.gov
January 26, 2021K200922Altus Spine HA Pedicle Screw SystemNKBSubstantially EquivalentAltus Partners, LLCaccessdata.fda.gov
June 2, 2020K200322Altus Spine Pedicle Screw SystemNKBSubstantially EquivalentAltus Partners, LLCaccessdata.fda.gov
May 29, 2019K183084Fuji Cervical Plate SystemKWQSubstantially EquivalentAltus Partners, LLCaccessdata.fda.gov
February 22, 2019K182406Altus Spine Interbody Fusion SystemMAXSubstantially EquivalentAltus Partners, LLCaccessdata.fda.gov
July 24, 2018K181339Altus Spine Pedicle Screw SystemNKBSubstantially EquivalentAltus Partners, LLCaccessdata.fda.gov
June 11, 2018K181281Altus Spine Pedicle Screw SystemNKBSubstantially EquivalentAltus Partners, LLCaccessdata.fda.gov
December 1, 2017K170553Altus Spine Interbody Fusion SystemMAXSubstantially EquivalentAltus Partners, LLCaccessdata.fda.gov
November 21, 2017K172253Altus Spine Cervical Interbody Fusion SystemODPSubstantially EquivalentAltus Partners, LLCaccessdata.fda.gov
August 29, 2017K171329Altus Spine Titanium Interbody Fusion SystemMAXSubstantially EquivalentAltus Partners, LLCaccessdata.fda.gov
March 10, 2017K170512Altus Spine Titanium Interbody Fusion SystemMAXSubstantially EquivalentAltus Partners, LLCaccessdata.fda.gov
February 6, 2017K163061Altus Spine Cervical Plate SystemKWQSubstantially EquivalentAltus Partners, LLCaccessdata.fda.gov
January 25, 2017K160976Altus Spine Interbody Fusion SystemMAXSubstantially EquivalentAltus Partners, LLCaccessdata.fda.gov
October 16, 2015K151648Altus Spine Pedicle Screw System, Altus Spine MIS Pedicle Screw System, Valencia Pedicle Screw System, Valencia MIS Pedicle Screw SystemNKBSubstantially EquivalentAltus Partners, LLCaccessdata.fda.gov
October 31, 2013K132280ALTUS SPINE PEDICLE SCREW SYSTEMMNISubstantially EquivalentAltus Partnersaccessdata.fda.gov
August 5, 2009K091396CARDO MEDICAL ANTERIOR CERVICAL PLATE SYSTEMKWQSubstantially EquivalentCardo Medical Corp.accessdata.fda.gov

Compare with other makers

Updated May 8, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.