AVS TL PEEK SPACERS— 510(k) K083661

Substantially Equivalent

Stryker Corp.

FDA 510(k) clearance K083661 for AVS TL PEEK SPACERS, Substantially Equivalent on 2009-02-27. Applicant: Stryker Corp..

Clearance details

Applicant: Stryker Corp.
Product code: Code MAX
Advisory panel: Orthopedic
Date received: 2008-12-10
Decision date: 2009-02-27
Decision: Substantially Equivalent
Clearance type: Traditional
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.