Device Desk

Private service · Not FDA

FDA device establishment · Palm City, FL

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-3013843230As of September 30, 2026

ORTHO MAX INC

Registration 3013843230FEI 3013843230Palm City, FL

Owner/operator: Ortho Max Inc

  • Complaint File Establishment per 21 CFR 820.198

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
14
Added, last 12 months
14

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 14

CodeDeviceClassRegulationPremarket
MBIMICRO ZIP ANCHOR 0.9mm w/ white #2-0 Stitch Suture and two needles 12.7mm 1/2 Circle Cylinder tipFastener, Fixation, Nondegradable, Soft TissueAdded Jun 18, 2026Class 221 CFR 888.3040K223114
HRSMICRO VERSA HOOK PLATE 1.5mm 2H 9x7mmPlate, Fixation, BoneAdded May 21, 2026Class 221 CFR 888.3030K182718
HRSMICRO SCAPHOID VERSALOCK PLATE 1.5mm - LARGEPlate, Fixation, BoneAdded May 21, 2026Class 221 CFR 888.3030K260390
HRSVERSA TORXDRIVE LOW PROFILE SCREW 3.5/2.7x10mm T10Plate, Fixation, BoneAdded May 21, 2026Class 221 CFR 888.3030K242998
HRSTORXDRIVE LOCKING SCREW 2.4x10mmPlate, Fixation, BoneAdded May 21, 2026Class 221 CFR 888.3030K231684
HRSMICRO RECTANGULAR VERSA PLATE 1.5mm 12H 32.8x8.5mmPlate, Fixation, BoneAdded May 21, 2026Class 221 CFR 888.3030K242596
HRSVERSALOCK CENTRAL ANTERIOR CLAVICLE PLATE 04 HOLES 3.5mmPlate, Fixation, BoneAdded May 21, 2026Class 221 CFR 888.3030K243740
HWCVERSALOCK CENTRAL ANTERIOR CLAVICLE PLATE 04 HOLES 3.5mmScrew, Fixation, BoneAdded May 21, 2026Class 221 CFR 888.3040K243740
HWCTORXDRIVE LOCKING SCREW 2.4x10mmScrew, Fixation, BoneAdded May 21, 2026Class 221 CFR 888.3040K231684
HWCVERSA TORXDRIVE LOW PROFILE SCREW 3.5/2.7x10mm T10Screw, Fixation, BoneAdded May 21, 2026Class 221 CFR 888.3040K242998
HWCMICRO SCAPHOID VERSALOCK PLATE 1.5mm - LARGEScrew, Fixation, BoneAdded May 21, 2026Class 221 CFR 888.3040K260390
HWCMICRO VERSA HOOK PLATE 1.5mm 2H 9x7mmScrew, Fixation, BoneAdded May 21, 2026Class 221 CFR 888.3040K182718

and 2 more on your full dossier

What changed

  • Jun 18, 2026Listing added: MBI — MICRO ZIP ANCHOR 0.9mm w/ white #2-0 Stitch Suture and two needles 12.7mm 1/2 Circle Cylinder tip (K223114)
  • May 21, 2026Listing added: HRS — MICRO VERSA HOOK PLATE 1.5mm 2H 9x7mm (K182718)
  • May 21, 2026Listing added: HRS — MICRO SCAPHOID VERSALOCK PLATE 1.5mm - LARGE (K260390)
  • May 21, 2026Listing added: HRS — VERSA TORXDRIVE LOW PROFILE SCREW 3.5/2.7x10mm T10 (K242998)
  • May 21, 2026Listing added: HRS — TORXDRIVE LOCKING SCREW 2.4x10mm (K231684)
  • May 21, 2026Listing added: HRS — MICRO RECTANGULAR VERSA PLATE 1.5mm 12H 32.8x8.5mm (K242596)
  • May 21, 2026Listing added: HRS — VERSALOCK CENTRAL ANTERIOR CLAVICLE PLATE 04 HOLES 3.5mm (K243740)
  • May 21, 2026Listing added: HWC — VERSALOCK CENTRAL ANTERIOR CLAVICLE PLATE 04 HOLES 3.5mm (K243740)
  • May 21, 2026Listing added: HWC — TORXDRIVE LOCKING SCREW 2.4x10mm (K231684)
  • May 21, 2026Listing added: HWC — VERSA TORXDRIVE LOW PROFILE SCREW 3.5/2.7x10mm T10 (K242998)
  • May 21, 2026Listing added: HWC — MICRO SCAPHOID VERSALOCK PLATE 1.5mm - LARGE (K260390)
  • May 21, 2026Listing added: HWC — MICRO VERSA HOOK PLATE 1.5mm 2H 9x7mm (K182718)
  • May 21, 2026Listing added: HWC — MICRO RECTANGULAR VERSA PLATE 1.5mm 12H 32.8x8.5mm (K242596)
  • Aug 26, 2026Listing added: LXH — ACL Reamer - 10mm
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

Watch for mail that looks like it is from FDA and asks you to pay a company. You pay FDA’s fee only in FDA’s own system.

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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