DeviceClearance

Optetrak Advanced Patella— 510(k) K160484

Substantially Equivalent

Exactech, Inc.

FDA 510(k) clearance K160484 for Optetrak Advanced Patella, Substantially Equivalent on 2016-03-18. Applicant: Exactech, Inc.. Device class: 2.

Clearance details

Applicant
Exactech, Inc.
Product code
Code JWH
Device class
Class 2
Regulation
21 CFR 888.3560
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Gainesville, FL, US
Download summary PDFView on FDA.gov ↗

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More clearances from Exactech, Inc.

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Adverse events under product code JWH

product code JWH
Death
26
Injury
51,564
Malfunction
9,725
Other
9
Total
61,324

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 K160484

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 K160484.

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