Zimmer PSI Shoulder System— 510(k) K150730

Name: FDA 510(k) clearance K150730
Creator: U.S. Food and Drug Administration
Published: 2015-06-16

Substantially Equivalent

Zimmer

FDA 510(k) clearance K150730 for Zimmer PSI Shoulder System, Substantially Equivalent on 2015-06-16. Applicant: Zimmer. Device class: 2.

Clearance details

Applicant: Zimmer
Product code: Code KWT
Device class: Class 2
Regulation: 21 CFR 888.3650
Advisory panel: Orthopedic
Date received: 2015-03-20
Decision date: 2015-06-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Montreal, CA

Download summary PDF View on FDA.gov ↗

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K262173 — N22 Offset Humeral Head2026-09-08
K250713 — Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder Implants2025-12-01
K251686 — Tornier Humeral Reconstruction System Max (Tornier HRS Max)2025-10-30
K241944 — AGILON® XO Shoulder Replacement System2025-03-10
K241817 — InSet Total Shoulder System2025-02-11

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Adverse events under product code KWT

product code KWT

Injury: 2,467
Other: 2
Total: 2,469

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.