FDA.reportPublic FDA data

510(k) K072961

Device
LOTUS ULTRASONIC SYSTEM FOR CEMENTED IMPLANT EXTRACTION (USCIX)
Applicant
Sra Developments, Ltd.
510(k) number
K072961
Product code
JDX
Decision
Substantially Equivalent (SESE)
Decision date
2007-12-19
Date received
2007-10-19
Regulation
888.4580
Classification name
Instrument, Surgical, Sonic And Accessory/Attachment
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
MICHAEL J.R. YOUNG
Address
Bremridge House Ashburton, Devon GB TQ13 7JX TQ13 7JX

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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