PREVISION HIP SYSTEM WITH RECON RING— 510(k) K102424

Substantially Equivalent

Aesculap Implant Systems, LLC

FDA 510(k) clearance K102424 for PREVISION HIP SYSTEM WITH RECON RING, Substantially Equivalent on 2010-12-09. Applicant: Aesculap Implant Systems, LLC. Device class: 2.

Clearance details

Applicant
Aesculap Implant Systems, LLC
Product code
Code MEH
Device class
Class 2
Regulation
21 CFR 888.3353
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Center Valley, PA, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code MEH

product code MEH
Injury
2,021
Total
2,021

Source: openFDA MAUDE database, through . 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.