TriMed® Compression Screws
TriMed, Inc. · K243943
FDA-authorized Predetermined Change Control Plan
- Company
- TriMed, Inc.
- 510(k)/De Novo #
- K243943
- Decision date
- 2025-04-10
- Panel
- Orthopedic
- Pathway
- 510(k)
- Category
- Non-AI
- PCCP type
- Other
- Monitoring commitment
- Not stated
What this PCCP covers. Permits defined post-clearance changes
Other PCCPs from TriMed, Inc.
Other Orthopedic PCCPs
- K260216CD Horizon ModuLeX Fenestrated Screw Set; CD Horizon ModuLeX Spinal SystemMedtronic Sofamor Danek USA, Inc.2026-04-21Non-AII/O expansion
- K253331PressON Spinal Fixation SystemNexus Spine2025-10-14Non-AIUnknown
- K243973FIX-L PEEK PLIF and T-PLIF SystemJeil Medical Corporation2025-06-12Non-AIUnknown
- K243987TriMed Elbow and Forearm SystemTriMed, Inc.2025-03-19Non-AIUnknown
- K243999TriMed Ankle Fixation SystemTriMed, Inc.2025-03-19Non-AIHardware
Want the monitoring teardown?
We read the PCCP for TriMed® Compression Screws, then map the post-market monitoring that its modification protocol requires, including the deployment-period evidence most teams can't reconstruct at modification time. Sentir is the independent system of record that produces it.
Book a callSource: U.S. FDA public records (openFDA 510(k)/De Novo databases and accessdata.fda.gov). PCCP type and category are editorial classifications based on public documents, not official FDA designations.
This page is a factual summary of public FDA records. Sentir Health is not affiliated with or endorsed by the named companies or the U.S. Food and Drug Administration. Spot an error? Request a correction.