TiWAVE-C Porous Titanium Cervical Cage— 510(k) K180401

Name: FDA 510(k) clearance K180401
Creator: U.S. Food and Drug Administration
Published: 2018-06-14

Substantially Equivalent

Kalitec Direct, LLC

FDA 510(k) clearance K180401 for TiWAVE-C Porous Titanium Cervical Cage, Substantially Equivalent on 2018-06-14. Applicant: Kalitec Direct, LLC. Device class: 2.

Clearance details

Applicant: Kalitec Direct, LLC
Product code: Code ODP
Device class: Class 2
Regulation: 21 CFR 888.3080
Advisory panel: Orthopedic
Date received: 2018-02-14
Decision date: 2018-06-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Orlando, FL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code ODP

view all

K262595 — VariLift-C Cervical Interbody Fusion System2026-08-26
K262489 — BluEX Cervical Expandable Cage System2026-08-18
K253041 — 3d Cage Cervical2026-07-23
K262061 — Tritanium® C Anterior Cervical Cage +16 more2026-07-17
K254130 — C.A. Medical Interbody Fusion System2026-07-08

More clearances from Kalitec Direct, LLC

view all

K172808 — CosmoLock Pedicle Screw System2017-10-25
K172086 — Matira Anterior Cervical System2017-09-22
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 ODP

product code ODP

Injury: 310
Total: 310

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.