JATEX, INC.

FDA Device Registration & Listing · Nappanee, IN, US · Registration 3010049501

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
3010049501
FEI Number
3010049501
Entity Name
JATEX, INC.
City/State/Country
Nappanee, IN, US
Establishment Address
551 Shawnee Drive, Nappanee, IN 46550, US
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
Jatex, Inc. (Owner Number: 10043044)
Owner / Operator Contact Address
551 Shawnee Drive, Nappanee, IN 46550, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

ENDOSKELETON TC Plate Bender Autobahn Evo Plate Inserter DRIVER, PROSTHESIS Fixation fusion Fusion AWL

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
PML Bone Cement, Posterior Screw Augmentation Orthopedic Class 2 888.3027 2026-01-12
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2026-01-12
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2026-01-12
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2024-04-22
HXP Instrument, Bending Or Contouring Orthopedic Class 1 888.4540 2013-01-31
HSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3520 2026-01-12
JDS Nail, Fixation, Bone Orthopedic Class 2 888.3030 2025-01-22
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2025-01-22
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2025-01-22
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2026-01-12
LXH Orthopedic Manual Surgical Instrument Orthopedic Class 1 888.4540 2013-01-22
HWR Driver, Prosthesis Orthopedic Class 1 888.4540 2013-01-31
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2026-01-12
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2026-01-12
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2026-01-12
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 2026-01-12
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2026-01-12
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2026-01-12
HRX Arthroscope Orthopedic Class 2 888.1100 2026-01-12
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2026-01-12
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2026-01-12
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2026-01-12
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2026-01-12
JDS Nail, Fixation, Bone Orthopedic Class 2 888.3030 2019-12-12
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2019-12-12
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2019-12-12
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2026-01-12
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2026-01-12
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2026-01-12
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2026-01-12
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2026-01-12
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2026-01-12
OUR Sacroiliac Joint Fixation Orthopedic Class 2 888.3040 2026-01-12
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2026-01-12
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2019-12-12
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2019-12-12
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2026-01-12
HAW Neurological Stereotaxic Instrument Neurology Class 2 882.4560 2025-01-22
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2025-01-22
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2026-01-12
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2026-01-12
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2026-01-12
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2026-01-12
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2026-01-12
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2026-01-12
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2026-01-12
OSH Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis Orthopedic Class 2 888.3070 2026-01-12
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2026-01-12
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2026-01-12
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2026-01-12
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2026-01-12
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2026-01-12
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2026-01-12
KWI Prosthesis, Elbow, Hemi-, Radial, Polymer Orthopedic Class 2 888.3170 2026-01-12
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2026-01-12
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2026-01-12
HAW Neurological Stereotaxic Instrument Neurology Class 2 882.4560 2026-01-12
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2026-01-12
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2026-01-12
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2026-01-12
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2026-01-12
PHM Intervertebral Fusion Device With Bone Graft, Thoracic Orthopedic Class 2 888.3080 2019-12-12
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2019-12-12
HWJ Awl Orthopedic Class 1 888.4540 2013-01-31
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2026-01-12
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2026-01-12
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2026-01-12
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2026-01-12
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2026-01-12
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2026-01-12
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2026-01-12
HAW Neurological Stereotaxic Instrument Neurology Class 2 882.4560 2026-01-12
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2026-01-12
HTN Washer, Bolt Nut Orthopedic Class 2 888.3030 2026-01-12
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2026-01-12
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2026-01-12

Official Correspondent

Devon Hochstetler

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Jatex, Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K032752 R&B Surgical Solutions, LLC R&B SURGICAL SMARTPLATE CERVICAL PLATE SYSTEM 2003-12-03
K062643 Life Spine KINETIC ANTERIOR CERVICAL PLATE 2006-11-16
K163363 Surgtech, Inc. SurgTech Thoracolumbosacral (TLS) Posterior Fixation System 2017-04-05
K252461 Spinal Resources, Inc. Swedge™ Pedicle Screw Fixation System Bezier Rod 2026-01-13
K140696 Pioneer Surgical Technology, Inc. STREAMLINE TL SPINAL FIXATION SYSTEM 2014-04-10

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0036-2013 Medtronic Sofamor Danek USA Inc 2
ATLANTIS(R) Anterior Cervical Plate System VARIABLE ANGLE SCREW MODULE, REF 176-503, QTY: 1 EA, Rx only, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132. Orthopedic. This instrument is a precision device which may incorporate a measuring function and has uses as described on the label. Unless labeled for single use, this instrument may be re-used.
Z-0037-2013 Medtronic Sofamor Danek USA Inc 2
ATLANTIS(R) Anterior Cervical Plate System FIXED ANGLE SCREW MODULE, REF 176-504, QTY: 1 EA, Rx only, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132. Orthopedic. This instrument is a precision device which may incorporate a measuring function and has uses as described on the label. Unless labeled for single use, this instrument may be re-used.
Z-0038-2013 Medtronic Sofamor Danek USA Inc 2
PREMIER(R) Anterior Cervical Plate System SCREW BLOCK, REF 1860503, QTY: 1 EA, Rx only, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132. Orthopedic. This instrument is a precision device which may incorporate a measuring function and has uses as described on the label. Unless labeled for single use, this instrument may be re-used.
Z-0040-05 Zimmer Spine, Inc. 2
ATO Drill Guide Kit (All Through One Drill Guides Set), model number 07.00860.001, product is packaged in trays.
Z-0001-2013 Synthes USA HQ, Inc. 2
MIRS for MATRIX Spine System. Minimally Invasive Reduction Screw (MIRS) for percutaneous instrumentation of the thoracolumbar spine. The Synthes USS are non-cervial spinal fixation devices intended for posterior pedicle screw fixation (T1-S2/ilium), posterior hook fixation (T1-L5), or anterolateral fixation (T8-L5).

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010049501. Last updated year: 2026. Please use registration number 3010049501 when referencing this establishment in official correspondence.
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