REMINGTON MEDICAL, INC.
Registration 1056553FEI 1000132370ALPHARETTA, GA
Owner/operator: REMINGTON MEDICAL, INC.
- Develop Specifications But Do Not Manufacture At This Facility
- Manufacture Device in the United States for Export Only
- Manufacture Medical Device
- Manufacture Medical Device for Another Party (Contract Manufacturer)
- 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.
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The 2026 window
- Oct 1Window opens91 days left
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- Dec 1Our pay-by date30 days left
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- FDA fee, FY2027
- $13,785
- Our pay-by suggestion
- Dec 1
- Listed devices
- 52
- 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
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 52
| Code | Device | Class | Regulation | Premarket |
|---|---|---|---|---|
| KWP | Appliance, Fixation, Spinal InterlaminalOrthopedicAdded Jan 28, 2026 | Class 2 | 21 CFR 888.3050 | — |
| KWQ | Appliance, Fixation, Spinal Intervertebral BodyOrthopedicAdded Jan 28, 2026 | Class 2 | 21 CFR 888.3060 | — |
| EXF | DRAINAGE BAG (600-D) FamilyBag, Bile Collecting | Class 2 | 21 CFR 876.5010 | K990428 |
| PML | Bone Cement, Posterior Screw AugmentationOrthopedic | Class 2 | 21 CFR 888.3027 | — |
| DSA | Cable, Transducer And Electrode, Patient, (Including Connector)Cardiovascular | Class 2 | 21 CFR 870.2900 | — |
| DSA | 301-CG FamilyCable, Transducer And Electrode, Patient, (Including Connector) | Class 2 | 21 CFR 870.2900 | K971968 |
| DRA | Myelotec Video Guided Steerable CatheterCatheter, Steerable | Class 2 | 21 CFR 870.1280 | — |
| BSK | Cuff, Tracheal Tube, InflatableAnesthesiologyAdded Jan 28, 2026 | Class 2 | 21 CFR 868.5750 | — |
| GXY | SafeOp 3: Neural Informatix SystemElectrode, Cutaneous | Class 2 | 21 CFR 882.1320 | — |
| GXZ | SafeOp 3: Neural Informatix SystemElectrode, Needle | Class 2 | 21 CFR 882.1350 | — |
| IKN | SafeOp 3: Neural Informatix SystemElectromyograph, Diagnostic | Class 2 | 21 CFR 890.1375 | — |
| IKN | Electromyograph, DiagnosticPhysical Medicine | Class 2 | 21 CFR 890.1375 | — |
and 40 more on your full dossier
What changed
- Jan 28, 2026Listing added: KWP — Appliance, Fixation, Spinal Interlaminal
- Jan 28, 2026Listing added: KWQ — Appliance, Fixation, Spinal Intervertebral Body
- Jan 28, 2026Listing added: BSK — Cuff, Tracheal Tube, Inflatable
- Jan 28, 2026Listing added: GEI — Electrosurgical, Cutting & Coagulation & Accessories
- Nov 21, 2025Listing added: DPW — VascuChek (K251904)
- Jan 28, 2026Listing added: MAX — Intervertebral Fusion Device With Bone Graft, Lumbar
- Jan 28, 2026Listing added: PHM — Intervertebral Fusion Device With Bone Graft, Thoracic
- Jan 28, 2026Listing added: FST — Light, Surgical, Fiberoptic
- Jan 28, 2026Listing added: MNI — Orthosis, Spinal Pedicle Fixation
- Jan 28, 2026Listing added: MNH — Orthosis, Spondylolisthesis Spinal Fixation
- Jan 28, 2026Listing added: PLR — Spinal Vertebral Body Replacement Device - Cervical
- Jan 28, 2026Listing added: KCT — Sterilization Wrap Containers, Trays, Cassettes & Other Accessories