Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3017528621

FEI Number

3017528621

Entity Name

Elite Medical, LLC

City/State/Country

Cordova, TN, US

Establishment Address

7420 Goodlett Farms Pkwy, Cordova, TN 38016, 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

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
OVE	Intervertebral Fusion Device With Integrated Fixation, Cervical	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
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2019-12-09
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2019-12-09
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Orthopedic	Class 2	888.3080	2024-05-30
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2024-05-30
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2013-01-18
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2013-01-18
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2014-09-26
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2013-01-18
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
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2023-08-23
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2013-01-18
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2015-01-15
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2013-01-18
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2024-09-27
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2013-01-18
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
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
MRW	System, Facet Screw Spinal Device	Unknown	Class U	N/A	2013-01-18
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2025-08-04
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Orthopedic	Class 2	888.3080	2025-08-04
PHM	Intervertebral Fusion Device With Bone Graft, Thoracic	Orthopedic	Class 2	888.3080	2025-08-04
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2026-01-29
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2019-12-09
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
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
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
OVE	Intervertebral Fusion Device With Integrated Fixation, Cervical	Orthopedic	Class 2	888.3080	2024-11-11
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	2018-02-06
OVE	Intervertebral Fusion Device With Integrated Fixation, Cervical	Orthopedic	Class 2	888.3080	2017-11-30
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2016-11-22
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
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Orthopedic	Class 2	888.3080	2024-11-11
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	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
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2013-01-18
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Orthopedic	Class 2	888.3080	2017-11-30
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
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Orthopedic	Class 2	888.3080	2017-11-30

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
3009882675	Elite Medical, LLC	Bartlett, TN, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K032604	Co-Ligne AG	GII SPINAL FIXATION SYSTEM	2004-01-20
K964304	Osteonics Corp.	OSTEONICS SPINAL SYSTEM-TOPLOADING TRANSVERSE CONNECTOR ASSEMBLY	1997-01-17
K963639	Acromed Corp.	ACROMED PEDICLE SCREW	1996-11-14
K012175	Encore Orthopedics, Inc.	PASS SPINAL SYSTEM	2001-07-31
K042598	Zimmer, Inc.	PERIARTICULAR LOCKING PLATES AND SCREWS, 2357 AND 2359 SERIES	2004-10-29

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0026-2011	Zimmer Inc.	2	SpeedLink 5.5 Transverse Connector Short 39.5-44mm, non-sterile, 1302-55S
Z-0027-2011	Zimmer Inc.	2	SpeedLink 5.5 Transverse Connector Medium 43-51mm, non-sterile, 1302-55M
Z-0028-2011	Zimmer Inc.	2	SpeedLink 5.5 Transverse Connector Long 50-65mm, non-sterile, 1302-55L
Z-0029-2011	Zimmer Inc.	2	SpeedLink 5.5 Transverse Connector X-Long 60-75mm, non-sterile, 1302-55XL
Z-0030-2011	Zimmer Inc.	2	SpeedLink 6.0 Transverse Connector Short 39.5-44mm, non-sterile, 1304-60S

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3017528621. Last updated year: 2026. Please use registration number 3017528621 when referencing this establishment in official correspondence.