CAIS STAPLE


Device Classification Name

staple, fixation, bone

510(k) Number K073281
Device Name CAIS STAPLE
Applicant
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY
325 paramount dr.
raynham, 
MA 
02767

Applicant Contact ruth c forstadt
Correspondent
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY
325 paramount dr.
raynham, 
MA 
02767

Correspodent Contact ruth c forstadt
Regulation Number 888.3030
Classification Product Code
JDR  
Date Received 11/21/2007
Decision Date 05/02/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No