TriMed Elbow and Forearm System
TriMed, Inc. · K243987
FDA-authorized Predetermined Change Control Plan
- Company
- TriMed, Inc.
- 510(k)/De Novo #
- K243987
- Decision date
- 2025-03-19
- Panel
- Orthopedic
- Pathway
- 510(k)
- Category
- Non-AI
- PCCP type
- Unknown
- Monitoring commitment
- Unknown
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
- K243943TriMed® Compression ScrewsTriMed, Inc.2025-04-10Non-AIOther
- K243999TriMed Ankle Fixation SystemTriMed, Inc.2025-03-19Non-AIHardware
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We read the PCCP for TriMed Elbow and Forearm System, 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.
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