DOLOMITE Anterior Cervical Stabilization System— 510(k) K202065

Name: FDA 510(k) clearance K202065
Creator: U.S. Food and Drug Administration
Published: 2020-10-26

Substantially Equivalent

Astura Medical, LLC

FDA 510(k) clearance K202065 for DOLOMITE Anterior Cervical Stabilization System, Substantially Equivalent on 2020-10-26. Applicant: Astura Medical, LLC. Device class: 2.

Clearance details

Applicant: Astura Medical, LLC
Product code: Code OVE
Device class: Class 2
Regulation: 21 CFR 888.3080
Advisory panel: Orthopedic
Date received: 2020-07-27
Decision date: 2020-10-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irving, TX, US

Download summary PDF View on FDA.gov ↗

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K261882 — Pisces-SC Standalone Cervical Interbody System2026-08-21
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K262094 — E3D-C Interbody System2026-07-22
K261279 — DeltaNEC Interbody System2026-06-22
K252982 — CONDUIT ZERO-P VA Secured Spacer System2026-06-18

More clearances from Astura Medical, LLC

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K202495 — SIRION Lateral Lumbar Interbody Fusion2021-01-06
K192492 — EL CAPITAN Anterior Lumber Interbody System2020-04-21
K192006 — SIRION Lateral Lumbar Interbody System2020-04-02
K190426 — ALTA Anterior Cervical Corpectomy System2019-10-24
K182877 — HALF DOME Posterior Lumbar Interbody System2019-05-03

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.