DeviceClearance

STRYKER COMPARTMENTAL KNEE SYSTEM— 510(k) K052917

Substantially Equivalent

Howmedica Osteonics Corp.

FDA 510(k) clearance K052917 for STRYKER COMPARTMENTAL KNEE SYSTEM, Substantially Equivalent on 2005-12-27. Applicant: Howmedica Osteonics Corp.. Device class: 2.

Clearance details

Applicant
Howmedica Osteonics Corp.
Product code
Code NPJ
Device class
Class 2
Regulation
21 CFR 888.3560
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Mahwah, NJ, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code NPJ

product code NPJ
Injury
258
Total
258

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 K052917

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 K052917.

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