COMPANY
Acumed
Timeline
- FDA FDA 510(k) clearance: The Acumed Wrist Fixation System - 2.4mm Screws — K252356, Aug 21, 2025. Applicant at approval: Acumed, LLC. source ↗
- FDA FDA 510(k) clearance: The Acumed Wrist Fixation System - Plates; The Acumed Wrist Fixation System - Screws — K251132, Jul 14, 2025. Applicant at approval: Acumed, LLC. source ↗
- FDA FDA 510(k) clearance: The Acumed Wrist Fixation System — K251296, Jun 18, 2025. Applicant at approval: Acumed, LLC. source ↗
- FDA FDA 510(k) clearance: Acu-Sinch Knotless Mini — K243624, Jan 23, 2025. Applicant at approval: Acumed, LLC. source ↗
- Trial start —: Short Term Evaluation of SLIC Screw in Treatment of Scapholunate Injury source ↗
Clinical trials (lead sponsor) 1
| Record | Title | Phase | Status | Start | Primary completion |
|---|---|---|---|---|---|
| NCT02579694 | Short Term Evaluation of SLIC Screw in Treatment of Scapholunate Injury | Not listed | Terminated | 2015-09 | 2017-06 (actual) |
FDA records (last 2 years)
- FDA 510(k) clearance: The Acumed Wrist Fixation System - 2.4mm Screws — K252356, Aug 21, 2025. Applicant at approval: Acumed, LLC. source ↗
- FDA 510(k) clearance: The Acumed Wrist Fixation System - Plates; The Acumed Wrist Fixation System - Screws — K251132, Jul 14, 2025. Applicant at approval: Acumed, LLC. source ↗
- FDA 510(k) clearance: The Acumed Wrist Fixation System — K251296, Jun 18, 2025. Applicant at approval: Acumed, LLC. source ↗
- FDA 510(k) clearance: Acu-Sinch Knotless Mini — K243624, Jan 23, 2025. Applicant at approval: Acumed, LLC. source ↗
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