Matira Anterior Cervical System— 510(k) K172086

Name: FDA 510(k) clearance K172086
Creator: U.S. Food and Drug Administration
Published: 2017-09-22

Substantially Equivalent

Kalitec Direct, LLC

FDA 510(k) clearance K172086 for Matira Anterior Cervical System, Substantially Equivalent on 2017-09-22. Applicant: Kalitec Direct, LLC. Device class: 2.

Clearance details

Applicant: Kalitec Direct, LLC
Product code: Code KWQ
Device class: Class 2
Regulation: 21 CFR 888.3060
Advisory panel: Orthopedic
Date received: 2017-07-11
Decision date: 2017-09-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Orlando, FL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KWQ

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K261112 — CastleLoc-P Anterior Cervical Plate System2026-05-06
K260570 — corra cervical plating system2026-04-22
K260697 — VyPlate Anterior Cervical Plate System2026-03-27

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K170342 — Ocata Anterior Cervical System2017-05-09
K163471 — Kalitec Direct InSePtion MIS Fixation System2017-03-16
K140678 — COSMOLOCK PEDICLE SCREW SYSTEM2014-06-19

Adverse events under product code KWQ

product code KWQ

Death: 8
Injury: 1,212
Malfunction: 1,233
Total: 2,453

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.