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Syntec-Taichung Non-Sterile Small Orthopedic Fixation System (71100 +4 more)
FDA 510(k)Class II (US FDA 510(k))
510(k) K984364
Identifiers
- 510(k) Number
- K984364 FDA 510(k)
- FDA Product Code
- KTT 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)
Syntec-Taichung Non-Sterile Small Orthopedic Fixation System (71100 +4 more) by Syntec Scientific Corp. — Class II — FDA_510K — listed in FDA 510(k) — 5 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 | K984364 | Class II | Active |
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Manufacturer
- Manufacturer
- Syntec Scientific Corp.
Sources (1)
- FDA 510(k) K984364 24 fields · synced Jun 19, 2026