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Syntec-Taichung Non-Sterile Bone Plate And Screw Implants, Model#'s 222020-2481…

FDA 510(k)

Class II (US FDA 510(k))

510(k) K983495

by Syntec Scientific Corp.

Identifiers

510(k) Number
K983495 FDA 510(k)
FDA Product Code
HWC FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 888.3040 FDA 510(k)
Regulation Number
888.3040 FDA 510(k)
Advisory Committee
Orthopedic FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Syntec-Taichung Non-Sterile Bone Plate And Screw Implants, Model#'s 222020-2481… by Syntec Scientific Corp. — Class II — FDA_510K — listed in FDA 510(k)

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Syntec Scientific Corp.

Sources (1)

  • FDA 510(k) K983495 24 fields · synced Jun 18, 2026