SEVIIN REVERSE SHOULDER— 510(k) K120374

Substantially Equivalent

Ingen Orthopedics, LLC

FDA 510(k) clearance K120374 for SEVIIN REVERSE SHOULDER, Substantially Equivalent on 2012-07-09. Applicant: Ingen Orthopedics, LLC.

Clearance details

Applicant: Ingen Orthopedics, LLC
Product code: Code PHX
Advisory panel: Orthopedic
Date received: 2012-02-06
Decision date: 2012-07-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cranbury, NJ, US

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Adverse events under product code PHX

product code PHX

Death: 10
Injury: 9,705
Malfunction: 1,252
Total: 10,967

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.