TRIMED, INC.
Registration 2031009FEI 3001236812Santa Clarita, CA
Owner/operator: TRIMED, INC.
- Complaint File Establishment per 21 CFR 820.198
- Develop Specifications But Do Not Manufacture At This Facility
- Manufacture Medical Device
- 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
- Nov 3Where you stand58 days left
- Dec 1Our pay-by date30 days left
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- Dec 31Window closes0 days left
- FDA fee, FY2027
- $13,785
- Our pay-by suggestion
- Dec 1
- Listed devices
- 91
- Added, last 12 months
- 7
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 91
| Code | Device | Class | Regulation | Premarket |
|---|---|---|---|---|
| JDS | Small Fragment Plates and ScrewsNail, Fixation, Bone | Class 2 | 21 CFR 888.3030 | K951302 |
| HTY | EOS Small Bone Fixation SystemPin, Fixation, Smooth | Class 2 | 21 CFR 888.3040 | K112794 |
| HTY | Omnitech Large or TriMed Compression ScrewPin, Fixation, Smooth | Class 2 | 21 CFR 888.3040 | K093676 |
| NDL | TriMed Wrist Fixation System 3Pin, Fixation, Smooth, Metallic | Class 2 | 21 CFR 888.3040 | K222637 |
| NDL | TriMed Wrist Fixation SystemPin, Fixation, Smooth, Metallic | Class 2 | 21 CFR 888.3040 | K243987 |
| NDL | Radial Osteotomy SystemPin, Fixation, Smooth, Metallic | Class 2 | 21 CFR 888.3040 | K243569 |
| NDL | TriMed Ankle Fixation SystemPin, Fixation, Smooth, Metallic | Class 2 | 21 CFR 888.3040 | K243999 |
| NDL | TBW (Tension Band Wire)Pin, Fixation, Smooth, Metallic | Class 2 | 21 CFR 888.3040 | K010545 |
| HRS | ASET Foot Plating SystemPlate, Fixation, Bone | Class 2 | 21 CFR 888.3030 | K233863 |
| HRS | TriMed Wrist Fixation System 3Plate, Fixation, Bone | Class 2 | 21 CFR 888.3030 | K222637 |
| HRS | TriMed Bone PlatesPlate, Fixation, Bone | Class 2 | 21 CFR 888.3030 | K060041 |
| HRS | Ulnar Osteotomy SystemPlate, Fixation, Bone | Class 2 | 21 CFR 888.3030 | K250929 |
and 79 more on your full dossier
What changed
- Jul 20, 2026Listing added: HRS — TriMed Non-Spanning Wrist Fusion Plates (K262032)
- Nov 20, 2025Listing added: HRS — Distal Xtremities System (K252061)
- Jan 19, 2026Listing added: HRS — TriMed Volar Bearing Plates (K254002)
- May 28, 2026Listing added: HWC — Screw, Fixation, Bone (K261241)
- Nov 20, 2025Listing added: HWC — Distal Xtremities System (K252061)
- Aug 13, 2026Listing added: HWC — Large Compression Screws (K262344)
- Jul 20, 2026Listing added: HWC — TriMed Non-Spanning Wrist Fusion Plates (K262032)