DeviceClearance

ELEOS Limb Salvage System— 510(k) K161520

Substantially Equivalent

Onkos Surgical, Inc.

FDA 510(k) clearance K161520 for ELEOS Limb Salvage System, Substantially Equivalent on 2016-10-28. Applicant: Onkos Surgical, Inc.. Device class: 2.

Clearance details

Applicant
Onkos Surgical, Inc.
Product code
Code KRO
Device class
Class 2
Regulation
21 CFR 888.3510
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Parsippany, NJ, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code KRO

product code KRO
Death
19
Injury
4,841
Total
4,860

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K161520

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K161520.

Data sourced from openFDA. This site is unofficial and independent of the FDA.