XENCO MEDICAL LLC

FDA Device Registration & Listing · San Diego, CA, US · Registration 3011181154

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3011181154
FEI Number
3011181154
Entity Name
XENCO MEDICAL LLC
City/State/Country
San Diego, CA, US
Establishment Address
9930 Mesa Rim Road, San Diego, CA 92121, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device,Complaint File Establishment per 21 CFR 820.198
Owner / Operator
Xenco Medical, LLC (Owner Number: 10047563)
Owner / Operator Contact Address
9930 Mesa Rim Road, San Diego, CA 92121, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K173933
PMA Number
N/A

All Registered Proprietary Names

Xenco Medical Cervical Interbody System Argus Cervical Interbody System SETx Cervical Interbody System SETx Cervical Interbody System TrabeculeX Recovery App SetX Pedicle Screw System SetX Pedicle Screw System SetX Cervical Interbody System SETx Pedicle Screw System SETx Lumbar Interbody System SETx Cervical Interbody System Xenco Medical Cervical Plate System SETx Cervical Plate System Saratoga Cervical Brace TrabeculeX Bioactive Matrix

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2014-10-06
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2015-09-25
ION Exerciser, Non-Measuring Physical Medicine Class 1 890.5370 2023-09-30
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2017-11-30
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2017-11-30
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2017-11-30
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2017-11-30
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2017-11-30
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2017-11-30
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2017-11-30
NKG Posterior Cervical Screw System Orthopedic Class 2 888.3075 2017-11-30
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2015-09-25
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2015-09-25
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2015-09-25
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2015-09-25
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2016-04-11
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2016-04-11
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 2017-01-17
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2017-01-17
IQK Orthosis, Cervical Physical Medicine Class 1 890.3490 2020-10-19
MQV Filler, Bone Void, Calcium Compound Orthopedic Class 2 888.3045 2018-11-06

Official Correspondent

Jason Haider

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Xenco Medical, LLC
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K173933 Xenco Medical, LLC Sorrento Bioglass Bone Graft Substitute 2018-09-13
K161478 Xenco Medical, LLC Xenco Medical Posterior Cervical System 2016-09-06
K142269 Reliance Medical Systems, LLC Reliance Cervical IBF System 2015-06-09
K122085 Omni Surgical, LP Dba Spine360 STINGRAY CERVICAL CAGE 2012-10-17
K120275 Synthes (Usa), LLC SYNTHES ACIS/VERTEBRAL SPACER CR 2012-05-25

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0001-2013 Synthes USA HQ, Inc. 2
MIRS for MATRIX Spine System. Minimally Invasive Reduction Screw (MIRS) for percutaneous instrumentation of the thoracolumbar spine. The Synthes USS are non-cervial spinal fixation devices intended for posterior pedicle screw fixation (T1-S2/ilium), posterior hook fixation (T1-L5), or anterolateral fixation (T8-L5).
Z-0004-2008 Abbott Spine 2
PathFinder Bone Drill-Awl-Tap, a part of the PathFinder spinal stablization system, Part Number 1156-50.
Z-0005-2008 Abbott Spine 2
PathFinder Bone Drill-Awl-Tap, a part of the PathFinder spinal stabilization system, Part Number 1156-60.
Z-0020-06 Pioneer Surgical Technology 2
Pioneer Surgical brand Quantum Spinal Rod System Polyaxial Screw, length 45 mm; Catalog number 10-575-PA-45.
Z-0021-06 Pioneer Surgical Technology 2
Pioneer Surgical brand Quantum Spinal Rod System Polyaxial Screw, length 40 mm; Catalog number 10-575-PA-40.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011181154. Last updated year: 2026. Please use registration number 3011181154 when referencing this establishment in official correspondence.
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