Orthopedic PCCPs
6 of the 143 FDA-authorized PCCPs are in the Orthopedic panel. Here is the full list, newest first.
- 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
- K243987TriMed Elbow and Forearm SystemTriMed, Inc.2025-03-19Non-AIUnknown
- K243999TriMed Ankle Fixation SystemTriMed, Inc.2025-03-19Non-AIHardware
Other panels
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We read the Orthopedic PCCPs in this list, 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.