Device Desk

Private service · Not FDA

FDA device establishment · Durham, NC

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-3014833750As of September 30, 2026

restor3d, inc.

Registration 3014833750FEI 3014833750Durham, NC

Owner/operator: restor3d, inc.

  • Complaint File Establishment per 21 CFR 820.198
  • Manufacture 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
34
Added, last 12 months
12

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 34

CodeDeviceClassRegulationPremarket
OYKKinos Axiom PSR SystemAnkle Arthroplasty Implantation SystemClass 221 CFR 888.3110K223326
SAIOssera AFX SystemAnkle Fusion CageClass 221 CFR 888.3020K242356
PLFrestor3d Utility WedgeBone WedgeClass 221 CFR 888.3030K201314
PLFrestor3d Osteotomy WedgeBone WedgeClass 221 CFR 888.3030K191047
OQGVelora Acetabular CupHip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, UncementedAdded Dec 10, 2025Class 221 CFR 888.3358K252067
ODPrestor3d Cervical CageIntervertebral Fusion Device With Bone Graft, CervicalClass 221 CFR 888.3080K191812
MAXrestor3d Lumbar Interbody Fusion CageIntervertebral Fusion Device With Bone Graft, LumbarClass 221 CFR 888.3080K234087
MAXrestor3d Lumbar Interbody Fusion CageIntervertebral Fusion Device With Bone Graft, LumbarClass 221 CFR 888.3080K220523
OOGiTotal® Identity™ Cruciate Retaining 3DP Porous Knee Replacement SystemKnee Arthroplasty Implantation SystemAdded Nov 21, 2025Class 221 CFR 888.3560K243768
HTYOsseoREBAR NailPin, Fixation, SmoothClass 221 CFR 888.3040K211789
HRSrestor3d Utility WedgePlate, Fixation, BoneClass 221 CFR 888.3030K201314
HSNKinos Aeros Ankle SystemProsthesis, Ankle, Semi-Constrained, Cemented, Metal/PolymerClass 221 CFR 888.3110K242868

and 22 more on your full dossier

What changed

  • Dec 10, 2025Listing added: OQG — Velora Acetabular Cup (K252067)
  • Nov 21, 2025Listing added: OOG — iTotal® Identity™ Cruciate Retaining 3DP Porous Knee Replacement System (K243768)
  • Dec 10, 2025Listing added: LZO — Velora Acetabular Cup (K252067)
  • Dec 10, 2025Listing added: LPH — Velora Acetabular Cup (K252067)
  • Dec 10, 2025Listing added: MEH — Velora Acetabular Cup (K252067)
  • Nov 21, 2025Listing added: MBH — iTotal® Identity™ Cruciate Retaining 3DP Porous Knee Replacement System (K243768)
  • Nov 21, 2025Listing added: OIY — iTotal® Identity™ Cruciate Retaining 3DP Porous Knee Replacement System (K243768)
  • Nov 21, 2025Listing added: JWH — iTotal® Identity™ Cruciate Retaining 3DP Porous Knee Replacement System (K243768)
  • Jul 21, 2026Listing added: HSD — Veritas Hemi Shoulder (K260556)
  • May 20, 2026Listing added: QHE — Veritas Reverse Total Shoulder System (K253992)
  • Jul 21, 2026Listing added: PHX — Veritas Hemi Shoulder (K260556)
  • May 20, 2026Listing added: PHX — Veritas Reverse Total Shoulder System (K253992)
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

We keep this page current each week. We email you before each date in the window, and when FDA’s record shows you renewed.

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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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