SEVIIN SURFACE REPLACEMENT SHOULDER— 510(k) K130635

Name: FDA 510(k) clearance K130635
Creator: U.S. Food and Drug Administration
Published: 2013-08-26

Substantially Equivalent

Ingen Orthopedics, LLC

FDA 510(k) clearance K130635 for SEVIIN SURFACE REPLACEMENT SHOULDER, Substantially Equivalent on 2013-08-26. Applicant: Ingen Orthopedics, LLC. Device class: 2.

Clearance details

Applicant: Ingen Orthopedics, LLC
Product code: Code HSD
Device class: Class 2
Regulation: 21 CFR 888.3690
Advisory panel: Orthopedic
Date received: 2013-03-11
Decision date: 2013-08-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cranbury, NJ, US

Download summary PDF View on FDA.gov ↗

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More clearances from Ingen Orthopedics, LLC

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K131277 — SEVIIN FRACTURE SHOULDER2013-08-28
K120374 — SEVIIN REVERSE SHOULDER2012-07-09

Adverse events under product code HSD

product code HSD

Injury: 3,425
Malfunction: 531
Total: 3,956

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.