ISO-ELASTIC CERCLAGE SYSTEM


Device Classification Name

cerclage, fixation

510(k) Number K030256
Device Name ISO-ELASTIC CERCLAGE SYSTEM
Original Applicant
KINAMED, INC.
820 flynn rd.
camarillo, 
CA 
93012

Original Contact vineet sarin
Regulation Number 888.3010
Classification Product Code
JDQ  
Date Received 01/24/2003
Decision Date 10/21/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No