PLASMAFIT ACETABULAR CUP AND VITELENE INSERT— 510(k) K122783

Substantially Equivalent

Aesculap Implant System, Inc.

FDA 510(k) clearance K122783 for PLASMAFIT ACETABULAR CUP AND VITELENE INSERT, Substantially Equivalent on 2013-10-30. Applicant: Aesculap Implant System, Inc..

Clearance details

Applicant: Aesculap Implant System, Inc.
Product code: Code OQG
Advisory panel: Orthopedic
Date received: 2012-09-11
Decision date: 2013-10-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Center Valley, PA, US

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Adverse events under product code OQG

product code OQG

Injury: 249
Total: 249

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.