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Data / Medical devices / United States / Xenco Medical LLC

Xenco Medical LLC: FDA-registered device maker in San Diego, CA, United States, 13 510(k) clearances

Xenco Medical LLC is registered with the FDA (registration 3011181154) in San Diego, CA, United States. It lists 14 device types. The FDA files 13 510(k) clearances under its listings, the newest dated December 21, 2021. Registered through 2026. FDA data exported November 3, 2026.

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Get makers like this oneWatch Xenco Medical LLC
FDA registration number
3011181154
Address
9930 Mesa Rim Road, San Diego, CA, United States, 92121
Owner or operator
Xenco Medical, LLC (10047563)
Roles
Complaint file establishment, Manufacturer, Specification developer
First device listed
October 6, 2014
Registered through
2026
Brand names listed
Argus Cervical Interbody System, Cancellex Porous Titanium Lumbar Interbody, Multilevel CerviKit, SETx Cervical Interbody System, SETx Cervical Plate System, SETx Lumbar Interbody System, SETx Pedicle Screw System, Saratoga Cervical Brace and more

Devices it lists

DeviceProduct codeClassRoleSource
Appliance, Fixation, Spinal InterlaminalKWP2Complaint file establishment, Manufacturer, Specification developeraccessdata.fda.gov
Appliance, Fixation, Spinal Intervertebral BodyKWQ2Complaint file establishment, Manufacturer, Specification developeraccessdata.fda.gov
Device, Fixation, Tracheal TubeCBH1Complaint file establishment, Manufacturer, Specification developeraccessdata.fda.gov
Exerciser, Non-MeasuringION1Complaint file establishment, Manufacturer, Specification developeraccessdata.fda.gov
Filler, Bone Void, Calcium CompoundMQV2Complaint file establishment, Manufacturer, Specification developeraccessdata.fda.gov
Intervertebral Fusion Device With Bone Graft, CervicalODP2Complaint file establishment, Manufacturer, Specification developeraccessdata.fda.gov
Intervertebral Fusion Device With Bone Graft, LumbarMAX2Complaint file establishment, Manufacturer, Specification developeraccessdata.fda.gov
Intervertebral Fusion Device With Integrated Fixation, CervicalOVE2Complaint file establishment, Manufacturer, Specification developeraccessdata.fda.gov
Orthosis, CervicalIQK1Complaint file establishment, Manufacturer, Specification developeraccessdata.fda.gov
Orthosis, Lumbo-SacralIPY1Complaint file establishment, Manufacturer, Specification developeraccessdata.fda.gov
Orthosis, Spinal Pedicle FixationMNI2Complaint file establishment, Manufacturer, Specification developeraccessdata.fda.gov
Orthosis, Spondylolisthesis Spinal FixationMNH2Complaint file establishment, Manufacturer, Specification developeraccessdata.fda.gov
Posterior Cervical Screw SystemNKG2Complaint file establishment, Manufacturer, Specification developeraccessdata.fda.gov
Thoracolumbosacral Pedicle Screw SystemNKB2Complaint file establishment, Manufacturer, Specification 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
December 21, 2021K213456Xenco Medical Multilevel CerviKitKWQSubstantially EquivalentXenco Medical, LLCaccessdata.fda.gov
September 13, 2018K173933Sorrento Bioglass Bone Graft SubstituteMQVSubstantially EquivalentXenco Medical, LLCaccessdata.fda.gov
August 24, 2018K180373CancelleX Porous Titanium Lumbar Interbody DeviceMAXSubstantially EquivalentXenco Medical, LLCaccessdata.fda.gov
May 25, 2017K170611SETx Pedicle Screw SystemNKBSubstantially EquivalentXenco Medical, LLCaccessdata.fda.gov
October 21, 2016K160313Xenco Medical Cervical Interbody SystemOVESubstantially EquivalentXenco Medical, LLCaccessdata.fda.gov
September 6, 2016K161478Xenco Medical Posterior Cervical SystemNKGSubstantially EquivalentXenco Medical, LLCaccessdata.fda.gov
May 4, 2016K160986Xenco Medical Pedicle Screw SystemNKBSubstantially EquivalentXenco Medical, LLCaccessdata.fda.gov
December 11, 2015K152987Xenco Medical Cervical Interbody System, Xenco Medical Lumbar Interbody SystemODPSubstantially EquivalentXenco Medical, LLCaccessdata.fda.gov
September 10, 2015K152302Xenco Medical Cervical Interbody System (Argus)ODPSubstantially EquivalentXenco Medical, LLCaccessdata.fda.gov
September 4, 2015K151733Xenco Medical Pedicle Screw SystemNKBSubstantially EquivalentXenco Medical, LLCaccessdata.fda.gov
March 20, 2015K143158Xenco Medical Lumbar Interbody SystemMAXSubstantially EquivalentXenco Medical, LLCaccessdata.fda.gov
February 23, 2015K141429SORRENTO BONE GRAFT SUBSTITUTEMQVSubstantially EquivalentHaider Biologics, LLCaccessdata.fda.gov
September 3, 2014K140786XENCO MEDICAL CERVICAL INTERBODY SYSTEMODPSubstantially EquivalentXenco Medical, LLCaccessdata.fda.gov

Compare with other makers

Updated December 21, 2021. 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.