MICROPULSE INC
Registration 1834379FEI 1000306303Columbia City, IN
Owner/operator: Micropulse
- Manufacture Medical Device for Another Party (Contract Manufacturer)
- Reprocess Single-Use Device
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
- 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
- 221
- Added, last 12 months
- 50
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 221
| Code | Device | Class | Regulation | Premarket |
|---|---|---|---|---|
| KTT | ACUTE INNOVATIONS STERNAL FIXATION SYSTEMAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | Class 2 | 21 CFR 888.3030 | — |
| KWP | LANX SPINAL FIXATION SYSTEMAppliance, Fixation, Spinal Interlaminal | Class 2 | 21 CFR 888.3050 | — |
| KWP | VIRAGE OCT SPINAL FIXATION SYSTEMAppliance, Fixation, Spinal Interlaminal | Class 2 | 21 CFR 888.3050 | — |
| KWP | LANX POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM (PCFS)Appliance, Fixation, Spinal Interlaminal | Class 2 | 21 CFR 888.3050 | — |
| KWP | SPINAL CONCEPTS INC. NEX-LINK SPINAL FIXATION SYSTEMAppliance, Fixation, Spinal Interlaminal | Class 2 | 21 CFR 888.3050 | — |
| KWP | OCTAFIX OCCIPITAL CERVICAL PLATING SYSTEMAppliance, Fixation, Spinal Interlaminal | Class 2 | 21 CFR 888.3050 | — |
| KWQ | MODIFICATION TO: LANX ANTERIOR CERVICAL PLATE SYSTEMAppliance, Fixation, Spinal Intervertebral Body | Class 2 | 21 CFR 888.3060 | — |
| KWQ | V2F ANTERIOR FIXATION SYSTEMAppliance, Fixation, Spinal Intervertebral Body | Class 2 | 21 CFR 888.3060 | — |
| KWQ | LANX ANTERIOR PLATING SYSTEMAppliance, Fixation, Spinal Intervertebral Body | Class 2 | 21 CFR 888.3060 | — |
| KWQ | SPINAL CONCEPTS, INC. (SCI) ANTERIOR CERVICAL PLATE SYSTEMAppliance, Fixation, Spinal Intervertebral Body | Class 2 | 21 CFR 888.3060 | — |
| KWQ | IdentiTiAppliance, Fixation, Spinal Intervertebral BodyAdded Aug 20, 2026 | Class 2 | 21 CFR 888.3060 | — |
| KWQ | ProximityAppliance, Fixation, Spinal Intervertebral BodyAdded Aug 20, 2026 | Class 2 | 21 CFR 888.3060 | — |
and 209 more on your full dossier
What changed
- Aug 20, 2026Listing added: KWQ — IdentiTi
- Aug 20, 2026Listing added: KWQ — Proximity
- Aug 20, 2026Listing added: ODP — IdentiTi
- Aug 20, 2026Listing added: ODP — IdentiTi
- Aug 20, 2026Listing added: ODP — IdentiTi NanoTec
- Aug 20, 2026Listing added: ODP — IdentiTi ll
- Aug 20, 2026Listing added: ODP — IdentiTi
- Aug 20, 2026Listing added: MAX — Transcend NanoTec
- Apr 16, 2026Listing added: MAX — Intervertebral Fusion Device With Bone Graft, Lumbar
- Aug 20, 2026Listing added: MAX — IdentiTi
- Aug 20, 2026Listing added: MAX — AMP II
- Aug 20, 2026Listing added: MAX — AMP
- Aug 20, 2026Listing added: MAX — IdentiTi NanoTec
- Aug 20, 2026Listing added: MAX — IdentiTi ll
- Aug 20, 2026Listing added: MAX — Battalion
- Aug 20, 2026Listing added: MAX — Calibrate
- Aug 20, 2026Listing added: MAX — AMP-LTX
- Aug 20, 2026Listing added: MAX — IdentiTi NanoTec
- Aug 20, 2026Listing added: MAX — IdentiTi
- Aug 20, 2026Listing added: MAX — IdentiTi
- Aug 20, 2026Listing added: PHM — AMP
- Aug 20, 2026Listing added: PHM — AMP II
- Aug 20, 2026Listing added: PHM — Transcend NanoTec
- Aug 20, 2026Listing added: PHM — IdentiTi
- Aug 20, 2026Listing added: PHM — IdentiTi NanoTec
- Aug 20, 2026Listing added: PHM — AMP-LTX
- Aug 20, 2026Listing added: PHM — IdentiTi
- Aug 20, 2026Listing added: PHM — IdentiTi
- Aug 20, 2026Listing added: PHM — IdentiTi NanoTec
- Aug 20, 2026Listing added: OVE — IdentiTi
- Aug 20, 2026Listing added: OVE — Transcend NanoTec
- Aug 20, 2026Listing added: OVE — IdentiTi
- Aug 20, 2026Listing added: OVD — IdentiTi
- Aug 20, 2026Listing added: OVD — AMP II
- Aug 20, 2026Listing added: OVD — Transcend NanoTec
- Aug 20, 2026Listing added: OVD — AMP
- Aug 20, 2026Listing added: OVD — IdentiTi NanoTec
- Aug 20, 2026Listing added: OVD — IdentiTi ll
- Apr 16, 2026Listing added: OVD — Intervertebral Fusion Device With Integrated Fixation, Lumbar
- Aug 20, 2026Listing added: OVD — IdentiTi
- Aug 20, 2026Listing added: OVD — IdentiTi NanoTec
- Aug 20, 2026Listing added: OVD — IdentiTi
- Aug 20, 2026Listing added: OVD — AMP-LTX
- Mar 30, 2026Listing added: KWT — Inhance 145 Degree Reverse Liner
- Mar 30, 2026Listing added: PAO — Inhance 145 Degree Reverse Liner
- Mar 30, 2026Listing added: KWS — Inhance 145 Degree Reverse Liner
- Mar 30, 2026Listing added: MBF — Inhance 145 Degree Reverse Liner
- Mar 30, 2026Listing added: PHX — Inhance 145 Degree Reverse Liner
- Aug 20, 2026Listing added: MQP — Ascend
- Aug 20, 2026Listing added: PLR — Ascend