LOTUS ULTRASONIC SYSTEM FOR CEMENTED IMPLANT EXTRACTION (USCIX)


Device Classification Name

instrument, surgical, sonic and accessory/attachment

510(k) Number K072961
Device Name LOTUS ULTRASONIC SYSTEM FOR CEMENTED IMPLANT EXTRACTION (USCIX)
Applicant
SRA DEVELOPMENTS, LTD.
bremridge house
ashburton, devon, 

GB

tq13 7jx

Applicant Contact michael j.r. young
Correspondent
SRA DEVELOPMENTS, LTD.
bremridge house
ashburton, devon, 

GB

tq13 7jx

Correspodent Contact michael j.r. young
Regulation Number 888.4580
Classification Product Code
JDX  
Date Received 10/19/2007
Decision Date 12/19/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

General & Plastic Surgery

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No