AESCULAP CESPACE XP— 510(k) K123909

Substantially Equivalent

Aesculap Implant System, Inc.

FDA 510(k) clearance K123909 for AESCULAP CESPACE XP, Substantially Equivalent on 2013-04-15. Applicant: Aesculap Implant System, Inc..

Clearance details

Applicant: Aesculap Implant System, Inc.
Product code: Code ODP
Advisory panel: Orthopedic
Date received: 2012-12-19
Decision date: 2013-04-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Center Valley, PA, 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.