Device Desk

Private service · Not FDA

FDA device establishment · Millcreek, UT

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

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Renewal dossierDD-3004719693As of September 30, 2026

INNOVASIS, INC.

Registration 3004719693FEI 3004719693Millcreek, UT

Owner/operator: Inno Holdings Inc.

  • Manufacture Medical Device
  • Repack or Relabel Medical 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

  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
60
Added, last 12 months
60

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 60

CodeDeviceClassRegulationPremarket
KWPExcella-M Spinal SystemAppliance, Fixation, Spinal InterlaminalAdded Dec 3, 2025Class 221 CFR 888.3050K042143
KWPExcella 3 Spinal SystemAppliance, Fixation, Spinal InterlaminalAdded Dec 3, 2025Class 221 CFR 888.3050K102248
KWPExcella Spinal SystemAppliance, Fixation, Spinal InterlaminalAdded Dec 3, 2025Class 221 CFR 888.3050K071921
KWPGibralt Posterior Cervical Spine SystemAppliance, Fixation, Spinal InterlaminalAdded Dec 3, 2025Class 221 CFR 888.3050K192354
KWPVector Pedicle Screw SystemAppliance, Fixation, Spinal InterlaminalAdded Dec 3, 2025Class 221 CFR 888.3050K241276
KWPExcella III-D Spinal Deformity SystemAppliance, Fixation, Spinal InterlaminalAdded Dec 3, 2025Class 221 CFR 888.3050K140238
KWQOpteryx Cervical Plate SystemAppliance, Fixation, Spinal Intervertebral BodyAdded Dec 3, 2025Class 221 CFR 888.3060K061147
KWQExcella 3 Spinal SystemAppliance, Fixation, Spinal Intervertebral BodyAdded Dec 3, 2025Class 221 CFR 888.3060K102248
KWQExcella-M Spinal SystemAppliance, Fixation, Spinal Intervertebral BodyAdded Dec 3, 2025Class 221 CFR 888.3060K042143
KWQOryx Cervical Plate SystemAppliance, Fixation, Spinal Intervertebral BodyAdded Dec 3, 2025Class 221 CFR 888.3060K192049
KWQKestrel Buttress Plate SystemAppliance, Fixation, Spinal Intervertebral BodyAdded Dec 3, 2025Class 221 CFR 888.3060K181063
KWQExcella III-D Spinal Deformity SystemAppliance, Fixation, Spinal Intervertebral BodyAdded Dec 3, 2025Class 221 CFR 888.3060K140238

and 48 more on your full dossier

What changed

  • Dec 3, 2025Listing added: KWP — Excella-M Spinal System (K042143)
  • Dec 3, 2025Listing added: KWP — Excella 3 Spinal System (K102248)
  • Dec 3, 2025Listing added: KWP — Excella Spinal System (K071921)
  • Dec 3, 2025Listing added: KWP — Gibralt Posterior Cervical Spine System (K192354)
  • Dec 3, 2025Listing added: KWP — Vector Pedicle Screw System (K241276)
  • Dec 3, 2025Listing added: KWP — Excella III-D Spinal Deformity System (K140238)
  • Dec 3, 2025Listing added: KWQ — Opteryx Cervical Plate System (K061147)
  • Dec 3, 2025Listing added: KWQ — Excella 3 Spinal System (K102248)
  • Dec 3, 2025Listing added: KWQ — Excella-M Spinal System (K042143)
  • Dec 3, 2025Listing added: KWQ — Oryx Cervical Plate System (K192049)
  • Dec 3, 2025Listing added: KWQ — Kestrel Buttress Plate System (K181063)
  • Dec 3, 2025Listing added: KWQ — Excella III-D Spinal Deformity System (K140238)
  • Dec 3, 2025Listing added: GXR — ICS (K141644)
  • Dec 3, 2025Listing added: GXR — Neuro & Craniofacial Fixation System (K141452)
  • Dec 3, 2025Listing added: HBW — Neuro & Craniofacial Fixation System (K141452)
  • Dec 3, 2025Listing added: HBW — ICS (K141644)
  • Dec 3, 2025Listing added: ODP — C-Box PEEK Cervical IBF System (K132991)
  • Dec 3, 2025Listing added: ODP — HAtetracell-C Titanium Cervical IBF System (K231899)
  • Dec 3, 2025Listing added: ODP — CxHA PEEK Cervical IBF System (K181115)
  • Dec 3, 2025Listing added: MAX — PxHA PEEK IBF System (K151785)
  • Dec 3, 2025Listing added: MAX — Px PEEK IBF System (K180078)
  • Dec 3, 2025Listing added: MAX — A-Box PEEK IBF System (K121581)
  • Dec 3, 2025Listing added: MAX — AxTiHA Stand-Alone ALIF System (K201614)
  • Dec 3, 2025Listing added: MAX — LxHA PEEK Lateral IBF System (K190684)
  • Dec 3, 2025Listing added: MAX — SpineWorks ALD (K133340)
  • Dec 3, 2025Listing added: MAX — Px PEEK IBF System (K150500)
  • Dec 3, 2025Listing added: OVE — Endeavor Stand-Alone Cervical IBF System (K250076)
  • Dec 3, 2025Listing added: OVD — AxTiHA Stand-Alone ALIF System (K212967)
  • Dec 3, 2025Listing added: OVD — AxTiHA Stand-Alone ALIF System (K250603)
  • Dec 3, 2025Listing added: OVD — AxTiHA Stand-Alone ALIF System (K201614)
  • Dec 3, 2025Listing added: OVD — AxHA Stand-Alone ALIF System (K162236)
  • Dec 3, 2025Listing added: FST — TruView Light Cable (K200874)
  • Dec 3, 2025Listing added: OLO — Excella G-E Navigation Instruments (K251073)
  • Dec 3, 2025Listing added: OLO — Innovasis Navigation Instruments (K250182)
  • Dec 3, 2025Listing added: OLO — Excella M-S Navigation Instruments (K223511)
  • Dec 3, 2025Listing added: MNI — Excella 3 Spinal System (K102248)
  • Dec 3, 2025Listing added: MNI — Excella-M Spinal System (K042143)
  • Dec 3, 2025Listing added: MNI — SpineWorks FixxSure X-Link (K162143)
  • Dec 3, 2025Listing added: MNI — SpineWorks FixxSure X-Link (K081331)
  • Dec 3, 2025Listing added: MNI — Excella III-D Spinal Deformity System (K140238)
  • Dec 3, 2025Listing added: MNI — Excella Spinal System (K071921)
  • Dec 3, 2025Listing added: MNH — SpineWorks FixxSure X-Link (K081331)
  • Dec 3, 2025Listing added: MNH — Excella 3 Spinal System (K102248)
  • Dec 3, 2025Listing added: MNH — SpineWorks FixxSure X-Link (K162143)
  • Dec 3, 2025Listing added: MNH — Excella III-D Spinal Deformity System (K140238)
  • Dec 3, 2025Listing added: MNH — Excella-M Spinal System (K042143)
  • Dec 3, 2025Listing added: MNH — Excella Spinal System (K071921)
  • Dec 3, 2025Listing added: GWO — ICS (K141644)
  • Dec 3, 2025Listing added: GWO — Neuro & Craniofacial Fixation System (K141452)
  • Dec 3, 2025Listing added: NKG — Gibralt Posterior Cervical Spine System (K192354)
  • Dec 3, 2025Listing added: MQP — T-Box PEEK VBR System (K062151)
  • Dec 3, 2025Listing added: MQP — SpineWorks Stansion Matrix (K042600)
  • Dec 3, 2025Listing added: NKB — Excella III-D Spinal Deformity System (K140238)
  • Dec 3, 2025Listing added: NKB — Excella Spinal System (K071921)
  • Dec 3, 2025Listing added: NKB — Vector Pedicle Screw System (K241276)
  • Dec 3, 2025Listing added: NKB — Excella 3 Spinal System (K102248)
  • Dec 3, 2025Listing added: HTZ — Innovasis Disc Prep
  • Dec 3, 2025Listing added: KIJ — Neuro & Craniofacial Fixation System (K101563)
  • Dec 3, 2025Listing added: LXH — PSO
  • Dec 3, 2025Listing added: GAD — TruView Lateral Access System
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.

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