AVS AS PEEK Spacer— 510(k) K142251

Substantially Equivalent

Stryker Corporation

FDA 510(k) clearance K142251 for AVS AS PEEK Spacer, Substantially Equivalent on 2014-11-19. Applicant: Stryker Corporation.

Clearance details

Applicant: Stryker Corporation
Product code: Code ODP
Advisory panel: Orthopedic
Date received: 2014-08-14
Decision date: 2014-11-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Allendale, NJ, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code ODP

product code ODP

Injury: 310
Total: 310

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.