FDA 510(k)

MIKRON TRAUMA BONE PLATE& SCREW SYSTEM

Número K: K260277 · 2026-08-13

RequerenteMikron Makina San. ve Tic. Ltd. Sti.

Data da decisão2026-08-13

Código do produtoHRS

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

MIKRON TRAUMA BONE PLATE& SCREW SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Mikron Makina San. ve Tic. Ltd. Sti.. It received FDA 510(k) clearance on 2026-08-13 under 510(k) number K260277. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the MIKRON TRAUMA BONE PLATE& SCREW SYSTEM?

MIKRON TRAUMA BONE PLATE& SCREW SYSTEM is a medical device that received FDA 510(k) clearance on 2026-08-13. The listed applicant is Mikron Makina San. ve Tic. Ltd. Sti.. The 510(k) number is K260277.

When did MIKRON TRAUMA BONE PLATE& SCREW SYSTEM receive FDA 510(k) clearance?

MIKRON TRAUMA BONE PLATE& SCREW SYSTEM received FDA 510(k) clearance on 2026-08-13, under 510(k) number K260277.

Who is the listed applicant for MIKRON TRAUMA BONE PLATE& SCREW SYSTEM?

The FDA 510(k) record lists Mikron Makina San. ve Tic. Ltd. Sti. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MIKRON TRAUMA BONE PLATE& SCREW SYSTEM?

The FDA product code for MIKRON TRAUMA BONE PLATE& SCREW SYSTEM is HRS.

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Fonte oficial

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