SURGICAL DYNAMICS SPINAL RETRACTOR


definition

Device Classification Name

arthroscope

510(k) Number K002008
Device Name SURGICAL DYNAMICS SPINAL RETRACTOR
Original Applicant
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC
150 glover ave.
norwalk, 
CT 
06856

Original Contact jennifer e schuck
Regulation Number 888.1100
Classification Product Code
HRX  
Subsequent Product Code
GZT  
Date Received 07/03/2000
Decision Date 08/16/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

General & Plastic Surgery

Type Traditional
Reviewed by Third Party No

Combination Product

No