A.M. SURGICAL, INC.
Registration 2437731FEI 3001617730Nashua, NH
Owner/operator: A.M. SURGICAL, INC.
- Develop Specifications But Do Not Manufacture At This Facility
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
- Nov 3Where you stand58 days left
- Dec 1Our pay-by date30 days left
- Dec 15Two weeks left16 days left
- Dec 23Holiday week8 days left
- Dec 29Two days left2 days left
- Dec 31Window closes0 days left
- FDA fee, FY2027
- $13,785
- Our pay-by suggestion
- Dec 1
- Listed devices
- 13
- Added, last 12 months
- 4
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 13
| Code | Device | Class | Regulation | Premarket |
|---|---|---|---|---|
| LXT | CPX Tightening ToolAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite | Class 2 | 21 CFR 888.3030 | K042458 |
| HTY | Secure IM NailPin, Fixation, Smooth | Class 2 | 21 CFR 888.3040 | K180087 |
| HWC | Secure ScrewScrew, Fixation, Bone | Class 2 | 21 CFR 888.3040 | K191771 |
| NBH | EndoSleeveAccessories, Arthroscopic | Class 1 | 21 CFR 888.1100 | — |
| HWJ | IM Nail AWLAwlAdded Jun 4, 2026 | Class 1 | 21 CFR 888.4540 | — |
| GEA | Clear Plastic CannulaCannula, Surgical, General & Plastic Surgery | Class 1 | 21 CFR 878.4800 | — |
| GEG | ElevatorElevator, Surgical, General & Plastic Surgery | Class 1 | 21 CFR 878.4800 | — |
| EMF | Endoscopic BladeKnife, Surgical | Class 1 | 21 CFR 878.4800 | — |
| LXH | Dilator-LargeOrthopedic Manual Surgical Instrument | Class 1 | 21 CFR 888.4540 | — |
| IOY | Velcro StrapSupport, ArmAdded Jun 11, 2026 | Class 1 | 21 CFR 890.3475 | — |
| FSE | Hand TableTable, Operating-Room, Manual | Class 1 | 21 CFR 878.4950 | — |
| JEB | Table PadTable, Surgical With Orthopedic Accessories, ManualAdded Jun 4, 2026 | Class 1 | 21 CFR 878.4950 | — |
and 1 more on your full dossier
What changed
- Jun 4, 2026Listing added: HWJ — IM Nail AWL
- Jun 11, 2026Listing added: IOY — Velcro Strap
- Jun 4, 2026Listing added: JEB — Table Pad
- Jun 4, 2026Listing added: FSM — Endo Tray