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TriMed Wrist Fixation System - TriMed Wrist Fixation System (Wireforms)
FDA 510(k)Class II (US FDA 510(k))
510(k) K243569
by Trimed, INC.
Identifiers
- 510(k) Number
- K243569 FDA 510(k)
- FDA Product Code
- HRS FDA 510(k)
- Models / Variants
- TriMed Wrist Fixation System (Hook Plates) FDA 510(k)TriMed Wrist Fixation System (Pin Plates) FDA 510(k)TriMed Wrist Fixation System (Peg Plates) FDA 510(k)TriMed Wrist Fixation System (Shear Plates) FDA 510(k)TriMed Wrist Fixation System (Wireforms) FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 888.3030 FDA 510(k)
- Regulation Number
- 888.3030 FDA 510(k)
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
TriMed Wrist Fixation System - TriMed Wrist Fixation System (Wireforms) by Trimed, INC. — Class II — FDA_510K — listed in FDA 510(k) — 10 models
Authorization Coverage (1 country)
Regulatory Authorizations
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K243569 | Class II | Active |
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Manufacturer
- Manufacturer
- Trimed, INC.
Sources (1)
- FDA 510(k) K243569 24 fields · synced Jun 18, 2026