INSTRU-MED TECHNOLOGIES
Registration 1833920FEI 1000115656Warsaw, IN
Owner/operator: Instrumedical Technologies, 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.
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The 2026 window
- Oct 1Window opens91 days left
- Nov 3Where you stand58 days left
- Dec 1Our pay-by date30 days left
- Dec 15Two weeks left16 days left
- Dec 23Holiday week8 days left
- Dec 29Two days left2 days left
- Dec 31Window closes0 days left
- FDA fee, FY2027
- $13,785
- Our pay-by suggestion
- Dec 1
- Listed devices
- 86
- Added, last 12 months
- 11
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
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 processWait 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 processRenew 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 listingReview 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 86
| Code | Device | Class | Regulation | Premarket |
|---|---|---|---|---|
| MJO | Prosthesis, Intervertebral DiscUnknown | Class 3 | — | — |
| KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple ComponentOrthopedic | Class 2 | 21 CFR 888.3030 | — |
| LXT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal CompositeOrthopedic | Class 2 | 21 CFR 888.3030 | — |
| KWP | Appliance, Fixation, Spinal InterlaminalOrthopedic | Class 2 | 21 CFR 888.3050 | — |
| KWP | HUDSON SLIDE HAMMERAppliance, Fixation, Spinal Interlaminal | Class 2 | 21 CFR 888.3050 | — |
| KWQ | Appliance, Fixation, Spinal Intervertebral BodyOrthopedic | Class 2 | 21 CFR 888.3060 | — |
| PML | Bone Cement, Posterior Screw AugmentationOrthopedicAdded Jan 29, 2026 | Class 2 | 21 CFR 888.3027 | — |
| OWI | Bone Fixation Cerclage, SublaminarOrthopedicAdded Jan 29, 2026 | Class 2 | 21 CFR 888.3010 | — |
| DSI | Detector And Alarm, ArrhythmiaCardiovascularAdded Jan 29, 2026 | Class 2 | 21 CFR 870.1025 | — |
| JDO | Device, Fixation, Proximal Femoral, ImplantOrthopedic | Class 2 | 21 CFR 888.3030 | — |
| MQV | Filler, Bone Void, Calcium CompoundOrthopedicAdded Jan 29, 2026 | Class 2 | 21 CFR 888.3045 | — |
| ODP | Intervertebral Fusion Device With Bone Graft, CervicalOrthopedic | Class 2 | 21 CFR 888.3080 | — |
and 74 more on your full dossier
What changed
- Jan 29, 2026Listing added: PML — Bone Cement, Posterior Screw Augmentation
- Jan 29, 2026Listing added: OWI — Bone Fixation Cerclage, Sublaminar
- Jan 29, 2026Listing added: DSI — Detector And Alarm, Arrhythmia
- Jan 29, 2026Listing added: MQV — Filler, Bone Void, Calcium Compound
- Aug 14, 2026Listing added: OVE — IdentiTi
- Jan 29, 2026Listing added: MWI — Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
- Jan 29, 2026Listing added: NKG — Posterior Cervical Screw System
- Jan 29, 2026Listing added: NQP — Posterior Metal/Polymer Spinal System, Fusion
- Jan 29, 2026Listing added: KCT — Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
- Jan 29, 2026Listing added: ETN — Stimulator, Nerve
- Jan 29, 2026Listing added: FIP — Subsystem, Water Purification