Intersomatic Cervical Device - DICOM PEEK, Intersomatic Intervertebral Space Maintenance Device - DIMEI PEEK, Intersomatic Transforaminal - TLIF PEEK— 510(k) K143572

Name: FDA 510(k) clearance K143572
Creator: U.S. Food and Drug Administration
Published: 2015-06-10

Substantially Equivalent

Osteomed Implantes, Ltda

FDA 510(k) clearance K143572 for Intersomatic Cervical Device - DICOM PEEK, Intersomatic Intervertebral Space Maintenance Device - DIMEI PEEK, Intersomatic Transforaminal - TLIF PEEK, Substantially Equivalent on 2015-06-10. Applicant: Osteomed Implantes, Ltda. Device class: 2.

Clearance details

Applicant: Osteomed Implantes, Ltda
Product code: Code ODP
Device class: Class 2
Regulation: 21 CFR 888.3080
Advisory panel: Orthopedic
Date received: 2014-12-17
Decision date: 2015-06-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rio Claro - Sp, BR

Download summary PDF View on FDA.gov ↗

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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.