CERVICAL CAGE— 510(k) K110915

Name: FDA 510(k) clearance K110915
Creator: U.S. Food and Drug Administration
Published: 2011-07-22

Substantially Equivalent

Eisertech, LLC

FDA 510(k) clearance K110915 for CERVICAL CAGE, Substantially Equivalent on 2011-07-22. Applicant: Eisertech, LLC. Device class: 2.

Clearance details

Applicant: Eisertech, LLC
Product code: Code ODP
Device class: Class 2
Regulation: 21 CFR 888.3080
Advisory panel: Orthopedic
Date received: 2011-04-01
Decision date: 2011-07-22
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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K254130 — C.A. Medical Interbody Fusion System2026-07-08

More clearances from Eisertech, LLC

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K192768 — Temporary Fixation Pins2019-12-26
K190565 — Cervical Plate2019-05-31
K140348 — INTERBODY CAGE2015-04-23
K142576 — Spinal System2015-02-26
K122444 — CERVICAL CAGE2012-08-30

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.