Device Desk

Private service · Not FDA

FDA device establishment · Nappanee, IN

This page shows the yearly renewal for this site, from FDA’s public record.

Device Desk is a private service. We are not FDA. We never file or pay for you.

Renewal dossierDD-3010049501As of September 30, 2026

JATEX, INC.

Registration 3010049501FEI 3010049501Nappanee, IN

Owner/operator: Jatex, Inc.

  • Manufacture Medical Device for Another Party (Contract Manufacturer)

Renewal due by December 31, 2026

Registered through 2026. Renew between October 1 and December 31, 2026, to stay registered for 2027.

90days left in the window

The 2026 window

  1. Oct 1Window opens91 days left
  2. Nov 3Where you stand58 days left
  3. Dec 1Our pay-by date30 days left
  4. Dec 15Two weeks left16 days left
  5. Dec 23Holiday week8 days left
  6. Dec 29Two days left2 days left
  7. Dec 31Window closes0 days left
an email on that date our pay-by date to December 31
FDA fee, FY2027
$13,785
Our pay-by suggestion
Dec 1
Listed devices
45
Added, last 12 months
22

FDA sets who pays the fee and who may qualify for a waiver; its fee page says so. The fee is paid only on FDA’s own fee site. Never through us. FDA’s fee page

The steps, in order

  1. Pay FDA's annual feeYou

    Order and pay the FY2027 establishment fee on FDA's Device Facility User Fee site. FDA emails you a PIN when you order.

    FDA: registration and listing payment process

  2. Wait for the payment confirmation numberYou

    FDA emails a Payment Confirmation Number (PCN) once the payment processes, which FDA says typically takes several days. That is why we suggest paying by December 1.

    FDA: registration and listing payment process

  3. Renew the registration in FDA's systemYou

    Sign in to FDA's Unified Registration and Listing System (FURLS), complete the annual registration and apply your PIN and PCN. FDA does not count the registration as complete until both are applied.

    FDA: device registration and listing

  4. Review every listingYou

    In the same window, review each listing on file and report any changes, deletions and new listings. Your Listing Review Sheet puts every listing on one page.

    FDA: device registration and listing

Every listed device 45

CodeDeviceClassRegulationPremarket
KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple ComponentOrthopedicAdded Jan 12, 2026Class 221 CFR 888.3030—
LXTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal CompositeOrthopedicAdded Jan 12, 2026Class 221 CFR 888.3030—
KWPAppliance, Fixation, Spinal InterlaminalOrthopedicAdded Jan 12, 2026Class 221 CFR 888.3050—
KWQAppliance, Fixation, Spinal Intervertebral BodyOrthopedicAdded Jan 12, 2026Class 221 CFR 888.3060—
HRXArthroscopeOrthopedicAdded Jan 12, 2026Class 221 CFR 888.1100—
PMLBone Cement, Posterior Screw AugmentationOrthopedicAdded Jan 12, 2026Class 221 CFR 888.3027—
ODPIntervertebral Fusion Device With Bone Graft, CervicalOrthopedicAdded Jan 12, 2026Class 221 CFR 888.3080—
ODPENDOSKELETON TCIntervertebral Fusion Device With Bone Graft, CervicalClass 221 CFR 888.3080—
MAXIntervertebral Fusion Device With Bone Graft, LumbarOrthopedicAdded Jan 12, 2026Class 221 CFR 888.3080—
MAXfusionIntervertebral Fusion Device With Bone Graft, LumbarClass 221 CFR 888.3080—
MAXFusionIntervertebral Fusion Device With Bone Graft, LumbarClass 221 CFR 888.3080—
PHMFusionIntervertebral Fusion Device With Bone Graft, ThoracicClass 221 CFR 888.3080—

and 33 more on your full dossier

What changed

  • Jan 12, 2026Listing added: KTT — Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
  • Jan 12, 2026Listing added: LXT — Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite
  • Jan 12, 2026Listing added: KWP — Appliance, Fixation, Spinal Interlaminal
  • Jan 12, 2026Listing added: KWQ — Appliance, Fixation, Spinal Intervertebral Body
  • Jan 12, 2026Listing added: HRX — Arthroscope
  • Jan 12, 2026Listing added: PML — Bone Cement, Posterior Screw Augmentation
  • Jan 12, 2026Listing added: ODP — Intervertebral Fusion Device With Bone Graft, Cervical
  • Jan 12, 2026Listing added: MAX — Intervertebral Fusion Device With Bone Graft, Lumbar
  • Jan 12, 2026Listing added: OVE — Intervertebral Fusion Device With Integrated Fixation, Cervical
  • Jan 12, 2026Listing added: OVD — Intervertebral Fusion Device With Integrated Fixation, Lumbar
  • Jan 12, 2026Listing added: MNI — Orthosis, Spinal Pedicle Fixation
  • Jan 12, 2026Listing added: MNH — Orthosis, Spondylolisthesis Spinal Fixation
  • Jan 12, 2026Listing added: OSH — Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis
  • Jan 12, 2026Listing added: HRS — Plate, Fixation, Bone
  • Jan 12, 2026Listing added: KWI — Prosthesis, Elbow, Hemi-, Radial, Polymer
  • Jan 12, 2026Listing added: HSX — Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
  • Jan 12, 2026Listing added: OUR — Sacroiliac Joint Fixation
  • Jan 12, 2026Listing added: HWC — Screw, Fixation, Bone
  • Jan 12, 2026Listing added: MQP — Spinal Vertebral Body Replacement Device
  • Jan 12, 2026Listing added: PLR — Spinal Vertebral Body Replacement Device - Cervical
  • Jan 12, 2026Listing added: NKB — Thoracolumbosacral Pedicle Screw System
  • Jan 12, 2026Listing added: HTN — Washer, Bolt Nut
Data provided by the U.S. Food and Drug Administration (https://open.fda.gov). FDA does not endorse Device Desk.FDA’s own record is always the authority.

How we got this date

  1. FDA asks every device site to renew its registration each year.
  2. The renewal window runs from October 1, 2026 to December 31, 2026.
  3. A renewal in this window covers 2027.
  4. The rule is 21 CFR 807.22(b).

FDA’s record shows this registration runs through 2026.

We read this from FDA’s public record on September 30, 2026.

Read FDA’s page on registration

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Keep this desk: $249 a year

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Renews each year until you cancel. Cancel any time from your account.

Is this right?

We copy this from FDA’s public record. FDA’s own record always wins. A listing missing here does not prove anything about FDA’s record.

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