UNIVERSAL CLAMP SPINAL FIXATION SYSTEM


Device Classification Name

bone fixation cerclage, sublaminar

510(k) Number K110348
Device Name UNIVERSAL CLAMP SPINAL FIXATION SYSTEM
Applicant
ZIMMER SPINE
7375 bush lake road
edina, 
MN 
55439

Applicant Contact elsa a linke
Correspondent
ZIMMER SPINE
7375 bush lake road
edina, 
MN 
55439

Correspodent Contact elsa a linke
Regulation Number 888.3010
Classification Product Code
OWI  
Date Received 02/07/2011
Decision Date 08/11/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No