Elite Medical, LLC

FDA Device Registration & Listing · Bartlett, TN, US · Registration 3009882675

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
3009882675
FEI Number
3009256700
Entity Name
Elite Medical, LLC
City/State/Country
Bartlett, TN, US
Establishment Address
8415 Wolf Lake Dr, Bartlett, TN 38133, US
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
Elite Medical, LLC (Owner Number: 10042156)
Owner / Operator Contact Address
8415 Wolf Lake Drive, Bartlett, TN 38133, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

MIDLINE II-TI

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2021-01-12
HAW Neurological Stereotaxic Instrument Neurology Class 2 882.4560 2021-01-12
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2013-01-18
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2013-01-18
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2013-01-18
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2016-11-22
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2019-07-10
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2019-07-10
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 2024-11-11
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2020-11-10
MRW System, Facet Screw Spinal Device Unknown Class U N/A 2013-01-18
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2017-11-30
JDS Nail, Fixation, Bone Orthopedic Class 2 888.3030 2018-12-20
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2024-11-11
OSH Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis Orthopedic Class 2 888.3070 2013-01-18
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2013-01-18
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2013-01-18
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2013-01-18
GAD Retractor General, Plastic Surgery Class 1 878.4800 2013-01-25
FZY Hammer, Surgical General, Plastic Surgery Class 1 878.4800 2013-12-31
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2019-12-09
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2019-12-09
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 2024-11-11
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2014-09-26
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2016-11-22
HXG Tamp Orthopedic Class 1 888.4540 2013-01-25
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2013-01-18
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2013-01-18
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2013-01-18
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2013-01-18
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2013-01-18
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2013-01-18
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2019-12-09
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2013-01-18
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2013-01-18
PEK Spinous Process Plate Orthopedic Class 2 888.3050 2024-01-08
LXH Orthopedic Manual Surgical Instrument Orthopedic Class 1 888.4540 2012-10-25
JDQ Cerclage, Fixation Orthopedic Class 2 888.3010 2013-01-18
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2013-01-18
PHM Intervertebral Fusion Device With Bone Graft, Thoracic Orthopedic Class 2 888.3080 2019-12-09
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2019-12-09
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2013-01-18
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2019-07-12
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2019-07-12
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2019-07-12
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2026-01-29
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2018-12-20
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2018-12-20
NKG Posterior Cervical Screw System Orthopedic Class 2 888.3075 2018-12-20
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2013-01-18
HXW Bender Orthopedic Class 1 888.4540 2013-01-25
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2019-07-12
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2019-07-12
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2019-07-12
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2019-07-12
FZX Guide, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 2013-01-18
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2013-01-18
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2013-01-18
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2013-01-18
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2015-01-15
HWX Tap, Bone Orthopedic Class 1 888.4540 2013-01-25
HTR Rasp General, Plastic Surgery Class 1 878.4800 2013-01-18
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2013-01-18
HXP Instrument, Bending Or Contouring Orthopedic Class 1 888.4540 2013-01-25
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 2017-11-30
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2016-03-11
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2016-03-11
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 2016-03-11
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2013-01-18
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2021-01-12
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2021-01-12
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 2024-11-11
HXC Wrench Orthopedic Class 1 888.4540 2013-01-25
HWJ Awl Orthopedic Class 1 888.4540 2013-01-18
HWA Impactor Orthopedic Class 1 888.4540 2013-01-18
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2013-01-18
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2013-01-18
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2013-01-18
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2019-12-09
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2018-02-06
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2023-08-23
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2013-01-18
IQO Device, Prosthesis Alignment Physical Medicine Class 1 890.3025 2013-01-18
HXX Screwdriver Orthopedic Class 1 888.4540 2013-01-18
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2013-01-18
HTW Bit, Drill Orthopedic Class 1 888.4540 2013-01-18
HXB Probe Orthopedic Class 1 888.4540 2013-01-25
HWR Driver, Prosthesis Orthopedic Class 1 888.4540 2013-01-18
MDM Instrument, Manual, Surgical, General Use General, Plastic Surgery Class 1 878.4800 2014-12-29

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

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

Other Registrations for Same Entity

Registration Number Establishment Name Location
3017565094 Elite Medical, LLC Florence, AL, US
3017528621 Elite Medical, LLC Cordova, TN, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K260601 Blue Belt Technologies, Inc. REAL INTELLIGENCE™ CORI™ 2026-03-26
K010427 Walter Lorenz Surgical, Inc. LORENZ FIDUCAIL SCREW 2001-03-15
K812744 Progress Mankind Technology LEVY BIOTAC #LX001 BIOPSY PROBE HOLDER 1981-12-03
K092467 Brainlab AG VECTORVISION CRANIAL, VECTORVISION ENT, KOLIBRI CRANIAL, KOLIBRI ENT, CRANIAL ESSENTIAL, CRANIAL UNLIMITED 2010-05-06
K031454 Biomet, Inc. ACUMEN SURGICAL NAVIGATION SYSTEM 2004-07-08

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0041-2024 Blue Belt Technologies, Inc 2
Real Intelligence CORI RI.KNEE v2.0 TKA (Total Knee Arthroplasty) software version 2.0 (2.0.0.5) Product Number: ROB10299
Z-0001-2012 Medtronic Navigation, Inc 2
Probe, Tactile, Left, ASM, Long, Part #962009S, Medtronic Navigation, Louisville, CO 80027. Trackable hand held instruments used in spine surgeries for preparation of the pedicle. These instruments are used in conjunction with the Medtronic Navigation StealthStation platform and various software applications.
Z-0002-2012 Medtronic Navigation, Inc 2
Probe, Tactile, Right, ASM, Long, Part #962011S, Medtronic Navigation, Louisville, CO 80027. Trackable hand held instruments used in spine surgeries for preparation of the pedicle. These instruments are used in conjunction with the Medtronic Navigation StealthStation platform and various software applications.
Z-0005-2007 Stryker Instruments Div. of Stryker Corporation 2
Stryker Navigation System, eNlite System with Dell laptop computer model D800, Stryker # 7700-300-000.
Z-0006-2007 Stryker Instruments Div. of Stryker Corporation 2
Stryker Navigation System Remote Planning Stations with Dell laptop computer model D800, Stryker # 7700-010-000 and 6000-300-000.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009882675. Last updated year: 2026. Please use registration number 3009882675 when referencing this establishment in official correspondence.
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