DeviceClearance

OPTETRAK LOGIC CR TIBIAL INSERT, OPTETRAK LOGIC CR FEMORAL COMPONENT— 510(k) K111400

Substantially Equivalent

Exactech, Inc.

FDA 510(k) clearance K111400 for OPTETRAK LOGIC CR TIBIAL INSERT, OPTETRAK LOGIC CR FEMORAL COMPONENT, Substantially Equivalent on 2011-07-28. Applicant: Exactech, Inc.. Device class: 2.

Clearance details

Applicant
Exactech, Inc.
Product code
Product 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 K111400

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 K111400.

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