Device Desk

Private service · Not FDA

FDA device establishment · Stamford, CT

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-3005972619As of September 30, 2026

ABYRX, INC.

Registration 3005972619FEI 3005972619Stamford, CT

Owner/operator: ORTHOCON, 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
49
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

  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 49

CodeDeviceClassRegulationPremarket
OISCalcium Salt Bone Void Filler, Drillable, Non-Screw AugmentationOrthopedicClass 221 CFR 888.3045K231270
OISMontage-XTCalcium Salt Bone Void Filler, Drillable, Non-Screw AugmentationClass 221 CFR 888.3045K233566
OISCalcium Salt Bone Void Filler, Drillable, Non-Screw AugmentationOrthopedicClass 221 CFR 888.3045K222063
OISCalcium Salt Bone Void Filler, Drillable, Non-Screw AugmentationOrthopedicClass 221 CFR 888.3045K231903
OISMontage Settable Bone PuttyCalcium Salt Bone Void Filler, Drillable, Non-Screw AugmentationClass 221 CFR 888.3045K242050
OISMontageCalcium Salt Bone Void Filler, Drillable, Non-Screw AugmentationAdded Nov 16, 2025Class 221 CFR 888.3045K243526
OISMontage-XTCalcium Salt Bone Void Filler, Drillable, Non-Screw AugmentationAdded Nov 16, 2025Class 221 CFR 888.3045K243506
GXRMontage Flowable Settable Resorbable Bone PasteCover, Burr HoleAdded Jul 14, 2026Class 221 CFR 882.5250K253447
MQVFiller, Bone Void, Calcium CompoundOrthopedicClass 221 CFR 888.3045K231270
MQVFiller, Bone Void, Calcium CompoundOrthopedicClass 221 CFR 888.3045K231903
MQVMontage-XTFiller, Bone Void, Calcium CompoundAdded Nov 16, 2025Class 221 CFR 888.3045K243506
MQVFiller, Bone Void, Calcium CompoundOrthopedicClass 221 CFR 888.3045K222063

and 37 more on your full dossier

What changed

  • Nov 16, 2025Listing added: OIS — Montage (K243526)
  • Nov 16, 2025Listing added: OIS — Montage-XT (K243506)
  • Jul 14, 2026Listing added: GXR — Montage Flowable Settable Resorbable Bone Paste (K253447)
  • Nov 16, 2025Listing added: MQV — Montage-XT (K243506)
  • Nov 16, 2025Listing added: MQV — Montage (K243526)
  • Jul 14, 2026Listing added: GXP — Montage XT Cranial Cement (K253854)
  • Jul 14, 2026Listing added: GXP — Permatage Flowable Settable Bone Paste (K253732)
  • Jul 14, 2026Listing added: GXP — Permatage XT Settable Bone Putty (K261265)
  • Jul 14, 2026Listing added: GXP — Montage Flowable Settable Resorbable Bone Paste (K253447)
  • Nov 16, 2025Listing added: MTJ — Montage-XT (K243506)
  • Jul 14, 2026Listing added: MTJ — Permatage Flowable Settable Hemostatic Bone Paste (K261439)
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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