Ascential IBD PEEKc Spacer— 510(k) K161407

Substantially Equivalent

Stryker Spine

FDA 510(k) clearance K161407 for Ascential IBD PEEKc Spacer, Substantially Equivalent on 2016-07-15. Applicant: Stryker Spine.

Clearance details

Applicant: Stryker Spine
Product code: Code ODP
Advisory panel: Orthopedic
Date received: 2016-05-20
Decision date: 2016-07-15
Decision: Substantially Equivalent
Clearance type: Special
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.