3M MODULAR SHOULDER SYSTEM— 510(k) K920362

Name: FDA 510(k) clearance K920362
Creator: U.S. Food and Drug Administration
Published: 1993-07-22

Substantially Equivalent

3M Health Care, Ltd.

FDA 510(k) clearance K920362 for 3M MODULAR SHOULDER SYSTEM, Substantially Equivalent on 1993-07-22. Applicant: 3M Health Care, Ltd.. Device class: 2.

Clearance details

Applicant: 3M Health Care, Ltd.
Product code: Code KWS
Device class: Class 2
Regulation: 21 CFR 888.3660
Advisory panel: Orthopedic
Date received: 1992-01-28
Decision date: 1993-07-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Paul, MN, US

Download summary PDF View on FDA.gov ↗

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K241292 — MyShoulder Planner (5.3SSWPL)2025-01-30

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K941748 — STERI-VAC GAS STERILIZER MODEL 8XL1994-12-02
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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.