CLS SPOTORNO STEM— 510(k) K042249

Name: FDA 510(k) clearance K042249
Creator: U.S. Food and Drug Administration
Published: 2004-09-15

Substantially Equivalent

Zimmer Austin, Inc.

FDA 510(k) clearance K042249 for CLS SPOTORNO STEM, Substantially Equivalent on 2004-09-15. Applicant: Zimmer Austin, Inc.. Device class: 2.

Clearance details

Applicant: Zimmer Austin, Inc.
Product code: Code LZO
Device class: Class 2
Regulation: 21 CFR 888.3353
Advisory panel: Orthopedic
Date received: 2004-08-19
Decision date: 2004-09-15
Decision: Substantially Equivalent
Clearance type: Special
Location: Austin, TX, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code LZO

product code LZO

Death: 17
Injury: 12,942
Malfunction: 1,756
Total: 14,715

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 K042249

K-number listed on FDA's recall record

Z-0234-2013 — CLS StemClass II·Terminated·Zimmer, Inc.·20120904

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K042249.

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