activL® Next Generation Instrumentation— 510(k) K231769

Name: FDA 510(k) clearance K231769
Creator: U.S. Food and Drug Administration
Published: 2023-07-13

Substantially Equivalent

Aesculap Implants Systems, LLC

FDA 510(k) clearance K231769 for activL® Next Generation Instrumentation, Substantially Equivalent on 2023-07-13. Applicant: Aesculap Implants Systems, LLC. Device class: 2.

Clearance details

Applicant: Aesculap Implants Systems, LLC
Product code: Code QLQ
Device class: Class 2
Regulation: 21 CFR 888.4515
Advisory panel: Orthopedic
Date received: 2023-06-16
Decision date: 2023-07-13
Decision: Substantially Equivalent
Clearance type: Special
Location: Center Valley, PA, US

Download summary PDF View on FDA.gov ↗

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