MedtechSourcebook

JATEX, INC.

Contract manufacturer ยท Nappanee, IN

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

2013Product codes first listed, by year (tallest: 18)2026
FDA registration
3010049501 (openFDA record; or search FDA's registration database)
FEI number
3010049501
Registered for
FDA registration year 2026
Establishment types
Contract manufacturer
Owner or operator
Jatex, Inc. (FDA owner/operator no. 10043044)
Registered address
551 Shawnee Drive, Nappanee, IN 46550
Contract listings
39 device listings, 36 product codes, first listed Jan 22, 2013
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 codeDevice (FDA name)ClassCategoryRoleFirst listed
FZXGuide, Surgical, InstrumentClass IGeneral and plastic surgeryContract manufacturingAug 12, 2024
HAWNeurological Stereotaxic InstrumentClass IINeurologyContract manufacturingJan 22, 2025
HRSPlate, Fixation, BoneClass IIOrthopedicContract manufacturingJan 12, 2026
HRXArthroscopeClass IIOrthopedicContract manufacturingJan 12, 2026
HSBRod, Fixation, Intramedullary And AccessoriesClass IIOrthopedicContract manufacturingDec 12, 2019
HSXProsthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/PolymerClass IIOrthopedicContract manufacturingJan 12, 2026
HTNWasher, Bolt NutClass IIOrthopedicContract manufacturingJan 12, 2026
HTOReamerClass IOrthopedicContract manufacturingJan 31, 2013
HWCScrew, Fixation, BoneClass IIOrthopedicContract manufacturingDec 12, 2019
HWJAwlClass IOrthopedicContract manufacturingJan 31, 2013
HWRDriver, ProsthesisClass IOrthopedicContract manufacturingJan 31, 2013
HWTTemplateClass IOrthopedicContract manufacturingJan 31, 2013
HXPInstrument, Bending Or ContouringClass IOrthopedicContract manufacturingJan 31, 2013
HXWBenderClass IOrthopedicContract manufacturingJan 31, 2013
HXXScrewdriverClass IOrthopedicContract manufacturingJan 31, 2013
JDSNail, Fixation, BoneClass IIOrthopedicContract manufacturingDec 12, 2019
KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple ComponentClass IIOrthopedicContract manufacturingJan 12, 2026
KWIProsthesis, Elbow, Hemi-, Radial, PolymerClass IIOrthopedicContract manufacturingJan 12, 2026
KWPAppliance, Fixation, Spinal InterlaminalClass IIOrthopedicContract manufacturingJan 12, 2026
KWQAppliance, Fixation, Spinal Intervertebral BodyClass IIOrthopedicContract manufacturingJan 12, 2026
LXHOrthopedic Manual Surgical InstrumentClass IOrthopedicContract manufacturingJan 22, 2013
LXTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal CompositeClass IIOrthopedicContract manufacturingJan 12, 2026
MAXIntervertebral Fusion Device With Bone Graft, LumbarClass IIOrthopedicContract manufacturingDec 12, 2019
MNHOrthosis, Spondylolisthesis Spinal FixationClass IIOrthopedicContract manufacturingJan 12, 2026
MNIOrthosis, Spinal Pedicle FixationClass IIOrthopedicContract manufacturingJan 12, 2026
MQPSpinal Vertebral Body Replacement DeviceClass IIOrthopedicContract manufacturingJan 12, 2026
NKBThoracolumbosacral Pedicle Screw SystemClass IIOrthopedicContract manufacturingJan 12, 2026
ODPIntervertebral Fusion Device With Bone Graft, CervicalClass IIOrthopedicContract manufacturingApr 22, 2024
OLOOrthopedic Stereotaxic InstrumentClass IINeurologyContract manufacturingDec 12, 2019
OSHPedicle Screw Spinal System, Adolescent Idiopathic ScoliosisClass IIOrthopedicContract manufacturingJan 12, 2026
OURSacroiliac Joint FixationClass IIOrthopedicContract manufacturingJan 12, 2026
OVDIntervertebral Fusion Device With Integrated Fixation, LumbarClass IIOrthopedicContract manufacturingDec 12, 2019
OVEIntervertebral Fusion Device With Integrated Fixation, CervicalClass IIOrthopedicContract manufacturingJan 12, 2026
PHMIntervertebral Fusion Device With Bone Graft, ThoracicClass IIOrthopedicContract manufacturingDec 12, 2019
PLRSpinal Vertebral Body Replacement Device - CervicalClass IIOrthopedicContract manufacturingJan 12, 2026
PMLBone Cement, Posterior Screw AugmentationClass IIOrthopedicContract manufacturingJan 12, 2026