The Integrity Spine Core System— 510(k) K223043

Name: FDA 510(k) clearance K223043
Creator: U.S. Food and Drug Administration
Published: 2023-03-20

Substantially Equivalent

Integrity Spine

FDA 510(k) clearance K223043 for The Integrity Spine Core System, Substantially Equivalent on 2023-03-20. Applicant: Integrity Spine. Device class: 2.

Clearance details

Applicant: Integrity Spine
Product code: Code ODP
Device class: Class 2
Regulation: 21 CFR 888.3080
Advisory panel: Orthopedic
Date received: 2022-09-22
Decision date: 2023-03-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Antonio, TX, US

Download summary PDF View on FDA.gov ↗

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K132718 — INTEGRITY SPINE CORE SYSTEM2013-11-18

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.