Non-Sterile Kirschner Wires And Steinmann Pins (#'s 290-101 +7 more)

FDA 510(k)

Class II (US FDA 510(k))

510(k) K983121

Identifiers

510(k) Number: K983121 FDA 510(k)
FDA Product Code: HTY FDA 510(k)
Models / Variants: #'s 290-101 FDA 510(k)
160 FDA 510(k)
290-201 FDA 510(k)
216 FDA 510(k)
290-060 FDA 510(k)
330 FDA 510(k)
290-161 FDA 510(k)
220 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)

Non-Sterile Kirschner Wires And Steinmann Pins (#'s 290-101 +7 more) by Syntec Scientific Corp. — Class II — FDA_510K — listed in FDA 510(k) — 8 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	K983121	Class II	Active

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Manufacturer

Manufacturer: Syntec Scientific Corp.

Sources (1)

FDA 510(k) K983121 24 fields · synced Jun 19, 2026