MIKRON TRAUMA BONE PLATE& SCREW SYSTEM— 510(k) K260277

Name: FDA 510(k) clearance K260277
Creator: U.S. Food and Drug Administration
Published: 2026-08-13

Substantially Equivalent

Mikron Makina San. ve Tic. Ltd. Sti.

FDA 510(k) clearance K260277 for MIKRON TRAUMA BONE PLATE& SCREW SYSTEM, Substantially Equivalent on 2026-08-13. Applicant: Mikron Makina San. ve Tic. Ltd. Sti.. Device class: 2.

Summary

Mikron Makina filed the MIKRON TRAUMA BONE PLATE& SCREW SYSTEM under product code HRS, bone fixation plates. The record gives no model numbers.

Class II, 21 CFR 888.3030. Orthopedic is both the classification panel and the review panel, and it came in as a Traditional 510(k).

Mikron filed from Yenimahalle, Turkey. The decision came 196 calendar days after receipt (January 29 to August 13, 2026), and it was substantially equivalent.

Clearance details

Applicant: Mikron Makina San. ve Tic. Ltd. Sti.
Product code: Product code HRS
Device class: Class 2
Regulation: 21 CFR 888.3030
Advisory panel: Orthopedic
Date received: 2026-01-29
Decision date: 2026-08-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Yenimahalle, TR

Download summary PDF View on FDA.gov ↗

Recent devices under product code HRS

view all

K261611 — TDM Large Bone Plate and Screw System2026-10-02
K262649 — Alians Forearm2026-09-28
K261892 — ProRib Fixation System2026-09-23
K262098 — EnHAnce PEEK Bunion System2026-09-18
K262963 — TMC Implant Fixation System2026-09-15

Adverse events under product code HRS

product code HRS

Death: 27
Injury: 10,340
Malfunction: 3,328
Total: 13,695

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.