DAYTONA ANTERIOR CERVICAL CAGE— 510(k) K110733

Name: FDA 510(k) clearance K110733
Creator: U.S. Food and Drug Administration
Published: 2011-08-25

Substantially Equivalent

Spinenet, LLC

FDA 510(k) clearance K110733 for DAYTONA ANTERIOR CERVICAL CAGE, Substantially Equivalent on 2011-08-25. Applicant: Spinenet, LLC. Device class: 2.

Clearance details

Applicant: Spinenet, LLC
Product code: Code ODP
Device class: Class 2
Regulation: 21 CFR 888.3080
Advisory panel: Orthopedic
Date received: 2011-03-16
Decision date: 2011-08-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Round Rock, TX, US

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 →

Recalls naming K110733

K-number listed on FDA's recall record

Z-2103-2013 — SpineNet Anterior Cervical Cage, Lordotic, Peek (originally submitted as Daytona Anterior Cervical Cage) Product Usage: Is indicated for use in skeletally mature patients with degenerative disc disease of the cervical spine with accompanying radicular symptoms at one disc levelClass II·Terminated·SpineNet·20130205

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K110733.

Data sourced from openFDA. This site is unofficial and independent of the FDA.