AESCULAP CESPACE PEEK INTERVERTEBRAL BODY FUSION SYSTEM— 510(k) K083311

Substantially Equivalent

Aesculap Implant Systems, Inc.

FDA 510(k) clearance K083311 for AESCULAP CESPACE PEEK INTERVERTEBRAL BODY FUSION SYSTEM, Substantially Equivalent on 2009-03-04. Applicant: Aesculap Implant Systems, Inc..

Clearance details

Applicant: Aesculap Implant Systems, Inc.
Product code: Code ODP
Advisory panel: Orthopedic
Date received: 2008-11-10
Decision date: 2009-03-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Center Valley, PA, US

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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.