ARDIS SPACER— 510(k) K073202

Name: FDA 510(k) clearance K073202
Creator: U.S. Food and Drug Administration
Published: 2008-01-30

Substantially Equivalent

Abbott Spine, Inc.

FDA 510(k) clearance K073202 for ARDIS SPACER, Substantially Equivalent on 2008-01-30. Applicant: Abbott Spine, Inc.. Device class: 2.

Clearance details

Applicant: Abbott Spine, Inc.
Product code: Code MAX
Device class: Class 2
Regulation: 21 CFR 888.3080
Advisory panel: Orthopedic
Date received: 2007-11-13
Decision date: 2008-01-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Austin, TX, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code MAX

product code MAX

Death: 13
Injury: 1,305
Malfunction: 2,885
Total: 4,203

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 K073202

K-number listed on FDA's recall record

Z-0594-2013 — Zimmer Spine Ardis Inserter, Rx, non-sterileClass I·Terminated·Zimmer, Inc.·20121112

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K073202.

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