DeviceClearance

DJO SURGICAL REVISION FEMORAL HIP SYSTEM, MODEL 428-14/24-140/200; 428-00-050/110— 510(k) K092331

Substantially Equivalent

Encore Medical L.P.

FDA 510(k) clearance K092331 for DJO SURGICAL REVISION FEMORAL HIP SYSTEM, MODEL 428-14/24-140/200; 428-00-050/110, Substantially Equivalent on 2010-03-03. Applicant: Encore Medical L.P.. Device class: 3.

Clearance details

Device name as filed
DJO SURGICAL REVISION FEMORAL HIP SYSTEM, MODEL 428-14/24-140/200; 428-00-050/110;
Applicant
Encore Medical L.P.
Product code
Code KWA
Device class
Class 3
Regulation
21 CFR 888.3330
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Austin, TX, US
Download summary PDFView on FDA.gov ↗

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More clearances from Encore Medical L.P.

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Adverse events under product code KWA

product code KWA
Death
38
Injury
10,439
Malfunction
1,862
Total
12,339

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 K092331

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 K092331.

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