LOTUS ULTRASONIC SYSTEM FOR CEMENTED IMPLANT EXTRACTION (USCIX)— 510(k) K072961

Name: FDA 510(k) clearance K072961
Creator: U.S. Food and Drug Administration
Published: 2007-12-19

Substantially Equivalent

Sra Developments, Ltd.

FDA 510(k) clearance K072961 for LOTUS ULTRASONIC SYSTEM FOR CEMENTED IMPLANT EXTRACTION (USCIX), Substantially Equivalent on 2007-12-19. Applicant: Sra Developments, Ltd.. Device class: 2.

Clearance details

Applicant: Sra Developments, Ltd.
Product code: Code JDX
Device class: Class 2
Regulation: 21 CFR 888.4580
Advisory panel: Orthopedic
Date received: 2007-10-19
Decision date: 2007-12-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ashburton, Devon, GB

Download summary PDF View on FDA.gov ↗

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