Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3017565094

FEI Number

3017565094

Entity Name

Elite Medical, LLC

City/State/Country

Florence, AL, US

Establishment Address

4001 Helton Drive, Florence, AL 35630, 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

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LXI	Guide, Drill, Ligament	General, Plastic Surgery	Class 1	878.4820	2024-04-04
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2018-12-20
HXC	Wrench	Orthopedic	Class 1	888.4540	2013-01-25
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2019-12-09
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2019-12-09
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2026-01-29
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Orthopedic	Class 2	888.3080	2016-11-22
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2012-10-25
HTJ	Gauge, Depth	Orthopedic	Class 1	888.4300	2014-12-29
HXP	Instrument, Bending Or Contouring	Orthopedic	Class 1	888.4540	2013-01-25
HXB	Probe	Orthopedic	Class 1	888.4540	2013-01-25
HWX	Tap, Bone	Orthopedic	Class 1	888.4540	2013-01-25
IQO	Device, Prosthesis Alignment	Physical Medicine	Class 1	890.3025	2013-01-18
FZY	Hammer, Surgical	General, Plastic Surgery	Class 1	878.4800	2013-12-31
HWN	Instrument, Compression	Orthopedic	Class 1	888.4540	2015-05-11
HWA	Impactor	Orthopedic	Class 1	888.4540	2013-01-18
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2019-12-09
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2019-12-09
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2019-12-09
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2019-12-09
HTR	Rasp	General, Plastic Surgery	Class 1	878.4800	2013-01-18
HXX	Screwdriver	Orthopedic	Class 1	888.4540	2013-01-18
HWJ	Awl	Orthopedic	Class 1	888.4540	2013-01-18
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2018-12-20
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2021-01-12
HAW	Neurological Stereotaxic Instrument	Neurology	Class 2	882.4560	2021-01-12
HXW	Bender	Orthopedic	Class 1	888.4540	2013-01-25
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

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
3017528621	Elite Medical, LLC	Cordova, TN, US
3009882675	Elite Medical, LLC	Bartlett, 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
K042598	Zimmer, Inc.	PERIARTICULAR LOCKING PLATES AND SCREWS, 2357 AND 2359 SERIES	2004-10-29
K190842	Jiangsu Trauhui Medical Instrument Co., Ltd.	Comus Locking Plate systems	2020-02-03
K130510	Arthrex, Inc.	ARTHREX COMPRESSION PLATES	2013-09-25
K202803	Newclip Technics	Activmotion S DTO	2021-12-16

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-0034-2022	Flower Orthopedics Corporation	2	Flower E-Kit, Advanced-Bone Fixation Fasterner-Fixation of Ref: EWK 201
Z-0014-2014	Synthes USA HQ, Inc.	2	Synthes Midfoot Fusion Bolt 6.5 mm. It is indicated for fracture, fixation, osteotomies, nonunions, and fusions of large bones in the foot and ankle.
Z-0026-2013	Orthohelix Surgical Designs Inc	2	OrthoHelix Part #HCS-056-32 3.2MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.
Z-0026-2016	Ortho Solutions Inc 330 Franklin Tnpk	2	Ortho OS Solutions UltOS 3.5mm locking screw 12mm to 50mm Ortho Solutions LTD, Unit 5 West Station Business Park, Spital Road, Maldon, Essex CM96FF Rx Only a) Sterile b) Non-Sterile Orthopaedic Bone Screw

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3017565094. Last updated year: 2026. Please use registration number 3017565094 when referencing this establishment in official correspondence.