DeviceClearance

LINK MP RECONSTRUCTION HIP— 510(k) K955296

Substantially Equivalent

Link America, Inc.

FDA 510(k) clearance K955296 for LINK MP RECONSTRUCTION HIP, Substantially Equivalent on 1996-02-14. Applicant: Link America, Inc.. Device class: 2.

Clearance details

Applicant
Link America, Inc.
Product code
Code JDI
Device class
Class 2
Regulation
21 CFR 888.3350
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Indianapolis, IN, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code JDI

product code JDI
Death
65
Injury
12,943
Malfunction
1,681
Total
14,689

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 K955296

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 K955296.

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