DeviceClearance

EXACTECH NOVATION EMPIRE ACETABULAR AUGMENT WITH INTEGRIP MODEL 186-01-08/11/13, 186-02-08/11/13, 186-03-08/11/13— 510(k) K101761

Substantially Equivalent

Exactech, Inc.

FDA 510(k) clearance K101761 for EXACTECH NOVATION EMPIRE ACETABULAR AUGMENT WITH INTEGRIP MODEL 186-01-08/11/13, 186-02-08/11/13, 186-03-08/11/13, Substantially Equivalent on 2010-09-21. Applicant: Exactech, Inc.. Device class: 2.

Clearance details

Applicant
Exactech, Inc.
Product code
Code LPH
Device class
Class 2
Regulation
21 CFR 888.3358
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
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 LPH

product code LPH
Death
73
Injury
31,640
Malfunction
3,358
Other
2
Total
35,073

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 K101761

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 K101761.

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