DYNESYS TOP-LOADING SPINAL SYSTEM


Device Classification Name

posterior metal/polymer spinal system, fusion

510(k) Number K073347
Device Name DYNESYS TOP-LOADING SPINAL SYSTEM
Applicant
ZIMMER SPINE, INC
7375 bush lake rd.
minneapolis, 
MN 
55439 -2027

Applicant Contact elsa a linke
Correspondent
ZIMMER SPINE, INC
7375 bush lake rd.
minneapolis, 
MN 
55439 -2027

Correspodent Contact elsa a linke
Regulation Number 888.3070
Classification Product Code
NQP  
Date Received 11/29/2007
Decision Date 02/08/2008
Decision

se – with limitations

(SESU)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls