Elite Medical, LLC

Contract manufacturer · Bartlett, TN

FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified

FDA registration: 3009882675 (openFDA record; or search FDA's registration database)
FEI number: 3009256700
Registered for: FDA registration year 2026
Establishment types: Contract manufacturer
Owner or operator: Elite Medical, LLC (FDA owner/operator no. 10042156)
Registered address: 8415 Wolf Lake Dr, Bartlett, TN 38133
Contract listings: 82 device listings, 53 product codes, first listed Oct 25, 2012
Certification: Not verified. We have no certification data for this facility yet.

Devices listed as contract work

Each row is an FDA product code this facility lists under its contract establishment type, with the date of its earliest such listing.

Product code	Device (FDA name)	Class	Category	Role	First listed
FZX	Guide, Surgical, Instrument	Class I	General and plastic surgery	Contract manufacturing	Jan 18, 2013
FZY	Hammer, Surgical	Class I	General and plastic surgery	Contract manufacturing	Dec 31, 2013
GAD	Retractor	Class I	General and plastic surgery	Contract manufacturing	Jan 25, 2013
GFI	Osteotome, Manual	Class I	General and plastic surgery	Contract manufacturing	Aug 28, 2026
HAW	Neurological Stereotaxic Instrument	Class II	Neurology	Contract manufacturing	Jan 12, 2021
HRS	Plate, Fixation, Bone	Class II	Orthopedic	Contract manufacturing	Dec 9, 2019
HRX	Arthroscope	Class II	Orthopedic	Contract manufacturing	Dec 9, 2019
HTE	Elevator	Class I	General and plastic surgery	Contract manufacturing	Aug 28, 2026
HTF	Curette	Class I	General and plastic surgery	Contract manufacturing	Aug 28, 2026
HTJ	Gauge, Depth	Class I	Orthopedic	Contract manufacturing	Dec 29, 2014
HTO	Reamer	Class I	Orthopedic	Contract manufacturing	Jan 18, 2013
HTQ	Broach	Class I	Orthopedic	Contract manufacturing	Jan 25, 2013
HTR	Rasp	Class I	General and plastic surgery	Contract manufacturing	Jan 18, 2013
HTW	Bit, Drill	Class I	Orthopedic	Contract manufacturing	Jan 18, 2013
HTZ	Instrument, Cutting, Orthopedic	Class I	General and plastic surgery	Contract manufacturing	Aug 28, 2026
HWA	Impactor	Class I	Orthopedic	Contract manufacturing	Jan 18, 2013
HWB	Extractor	Class I	Orthopedic	Contract manufacturing	Apr 13, 2015
HWC	Screw, Fixation, Bone	Class II	Orthopedic	Contract manufacturing	Dec 9, 2019
HWJ	Awl	Class I	Orthopedic	Contract manufacturing	Jan 18, 2013
HWN	Instrument, Compression	Class I	Orthopedic	Contract manufacturing	May 11, 2015
HWR	Driver, Prosthesis	Class I	Orthopedic	Contract manufacturing	Jan 18, 2013
HWT	Template	Class I	Orthopedic	Contract manufacturing	Jan 25, 2013
HWX	Tap, Bone	Class I	Orthopedic	Contract manufacturing	Jan 25, 2013
HXB	Probe	Class I	Orthopedic	Contract manufacturing	Jan 25, 2013
HXC	Wrench	Class I	Orthopedic	Contract manufacturing	Jan 25, 2013
HXD	Clamp	Class I	General and plastic surgery	Contract manufacturing	Jan 18, 2013
HXG	Tamp	Class I	Orthopedic	Contract manufacturing	Jan 25, 2013
HXL	Mallet	Class I	General and plastic surgery	Contract manufacturing	Aug 28, 2026
HXP	Instrument, Bending Or Contouring	Class I	Orthopedic	Contract manufacturing	Jan 25, 2013
HXW	Bender	Class I	Orthopedic	Contract manufacturing	Jan 25, 2013
HXX	Screwdriver	Class I	Orthopedic	Contract manufacturing	Jan 18, 2013
IQO	Device, Prosthesis Alignment	Class I	Physical medicine	Contract manufacturing	Jan 18, 2013
JDQ	Cerclage, Fixation	Class II	Orthopedic	Contract manufacturing	Jan 18, 2013
JDS	Nail, Fixation, Bone	Class II	Orthopedic	Contract manufacturing	Dec 20, 2018
KWP	Appliance, Fixation, Spinal Interlaminal	Class II	Orthopedic	Contract manufacturing	Jan 18, 2013
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Class II	Orthopedic	Contract manufacturing	Jan 18, 2013
LXH	Orthopedic Manual Surgical Instrument	Class I	Orthopedic	Contract manufacturing	Oct 25, 2012
LXI	Guide, Drill, Ligament	Class I	General and plastic surgery	Contract manufacturing	Apr 4, 2024
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Class II	Orthopedic	Contract manufacturing	Jan 18, 2013
MDM	Instrument, Manual, Surgical, General Use	Class I	General and plastic surgery	Contract manufacturing	Dec 29, 2014
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Class II	Orthopedic	Contract manufacturing	Jan 18, 2013
MNI	Orthosis, Spinal Pedicle Fixation	Class II	Orthopedic	Contract manufacturing	Jan 18, 2013
MQP	Spinal Vertebral Body Replacement Device	Class II	Orthopedic	Contract manufacturing	Jan 18, 2013
MRW	System, Facet Screw Spinal Device	Unclassified	Orthopedic	Contract manufacturing	Jan 18, 2013
NKB	Thoracolumbosacral Pedicle Screw System	Class II	Orthopedic	Contract manufacturing	Jan 18, 2013
NKG	Posterior Cervical Screw System	Class II	Orthopedic	Contract manufacturing	Dec 20, 2018
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Class II	Orthopedic	Contract manufacturing	Jan 18, 2013
OLO	Orthopedic Stereotaxic Instrument	Class II	Neurology	Contract manufacturing	Dec 20, 2018
OSH	Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis	Class II	Orthopedic	Contract manufacturing	Jan 18, 2013
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Class II	Orthopedic	Contract manufacturing	Jan 18, 2013
OVE	Intervertebral Fusion Device With Integrated Fixation, Cervical	Class II	Orthopedic	Contract manufacturing	Jan 18, 2013
PEK	Spinous Process Plate	Class II	Orthopedic	Contract manufacturing	Jan 8, 2024
PHM	Intervertebral Fusion Device With Bone Graft, Thoracic	Class II	Orthopedic	Contract manufacturing	Dec 9, 2019

Elite Medical, LLC

Devices listed as contract work

Other contract facilities of Elite Medical, LLC