DeviceClearance

ET PROSTHETIC SYSTEM— 510(k) K130662

Substantially Equivalent

Osstem Implant Co., Ltd.

FDA 510(k) clearance K130662 for ET PROSTHETIC SYSTEM, Substantially Equivalent on 2014-01-10. Applicant: Osstem Implant Co., Ltd.. Device class: 2.

Clearance details

Applicant
Osstem Implant Co., Ltd.
Product code
Code NHA
Device class
Class 2
Regulation
21 CFR 872.3630
Advisory panel
Dental
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Fariless Hills, PA, US
Download summary PDFView on FDA.gov ↗

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More clearances from Osstem Implant Co., Ltd.

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Adverse events under product code NHA

product code NHA
Injury
1,270
Malfunction
2,860
Total
4,130

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 K130662

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 K130662.

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