TOTAL AND HEMI SHOULDER SYSTEM— 510(k) K060988

Name: FDA 510(k) clearance K060988
Creator: U.S. Food and Drug Administration
Published: 2006-12-06

Substantially Equivalent

Dvo Extremity Solutions, LLC

FDA 510(k) clearance K060988 for TOTAL AND HEMI SHOULDER SYSTEM, Substantially Equivalent on 2006-12-06. Applicant: Dvo Extremity Solutions, LLC. Device class: 2.

Clearance details

Applicant: Dvo Extremity Solutions, LLC
Product code: Code KWS
Device class: Class 2
Regulation: 21 CFR 888.3660
Advisory panel: Orthopedic
Date received: 2006-04-10
Decision date: 2006-12-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Derby, CT, US

Download summary PDF View on FDA.gov ↗

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K252418 — Catalyst F1x Shoulder System2025-11-06
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K241292 — MyShoulder Planner (5.3SSWPL)2025-01-30

Adverse events under product code KWS

product code KWS

Death: 6
Injury: 9,652
Malfunction: 1,385
Other: 1
Total: 11,044

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.

Clearance details

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Adverse events under product code KWS