AVS PL PEEK SPACERS, MODELS 48351 AND 48353— 510(k) K080758

Substantially Equivalent

Stryker Corp.

FDA 510(k) clearance K080758 for AVS PL PEEK SPACERS, MODELS 48351 AND 48353, Substantially Equivalent on 2008-03-27. Applicant: Stryker Corp..

Clearance details

Applicant: Stryker Corp.
Product code: Code MAX
Advisory panel: Orthopedic
Date received: 2008-03-18
Decision date: 2008-03-27
Decision: Substantially Equivalent
Clearance type: Special
Location: Allendale, NJ, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code MAX

product code MAX

Death: 13
Injury: 1,305
Malfunction: 2,885
Total: 4,203

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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