Titus Titanium Cervical by SAGICO— 510(k) K221138

Name: FDA 510(k) clearance K221138
Creator: U.S. Food and Drug Administration
Published: 2023-08-04

Substantially Equivalent

Sagico VA USA, LLC

FDA 510(k) clearance K221138 for Titus Titanium Cervical by SAGICO, Substantially Equivalent on 2023-08-04. Applicant: Sagico VA USA, LLC. Device class: 2.

Clearance details

Applicant: Sagico VA USA, LLC
Product code: Code OVE
Device class: Class 2
Regulation: 21 CFR 888.3080
Advisory panel: Orthopedic
Date received: 2022-04-19
Decision date: 2023-08-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tampa, FL, US

Download summary PDF View on FDA.gov ↗

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K262094 — E3D-C Interbody System2026-07-22
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K252982 — CONDUIT ZERO-P VA Secured Spacer System2026-06-18

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K232561 — Ripley Spinal Screw System by SAGICO2023-10-23
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Adverse events under product code OVE

product code OVE

Injury: 293
Malfunction: 710
Total: 1,003

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.