DeviceClearance

SLED UNICOMPARTMENT KNEE SYSTEM— 510(k) K954186

Substantially Equivalent

Link America, Inc.

FDA 510(k) clearance K954186 for SLED UNICOMPARTMENT KNEE SYSTEM, Substantially Equivalent on 1996-01-26. Applicant: Link America, Inc.. Device class: 2.

Clearance details

Applicant
Link America, Inc.
Product code
Code HSX
Device class
Class 2
Regulation
21 CFR 888.3520
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
East Hanavor, NJ, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code HSX

product code HSX
Injury
1,003
Other
1
Total
1,004

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 K954186

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 K954186.

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