DeviceClearance

SURGICAL SIMPLEX P RADIOPAQUE BONE CEMENT AND ACM AND MIXEVACII— 510(k) K002652

Substantially Equivalent

Stryker Corp.

FDA 510(k) clearance K002652 for SURGICAL SIMPLEX P RADIOPAQUE BONE CEMENT AND ACM AND MIXEVACII, Substantially Equivalent on 2001-01-26. Applicant: Stryker Corp.. Device class: 2.

Clearance details

Applicant
Stryker Corp.
Product code
Code LOD
Device class
Class 2
Regulation
21 CFR 888.3027
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Portage, MI, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code LOD

product code LOD
Death
44
Injury
3,004
Malfunction
895
Other
4
Total
3,947

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 K002652

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 K002652.

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