VARIOUS


Device Classification Name

fastener, fixation, nondegradable, soft tissue

510(k) Number K112417
Device Name VARIOUS
Applicant
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY
325 paramount dr.
raynham, 
MA 
02767

Applicant Contact deep pal
Correspondent
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY
325 paramount dr.
raynham, 
MA 
02767

Correspodent Contact deep pal
Regulation Number 888.3040
Classification Product Code
MBI  
Date Received 08/23/2011
Decision Date 01/13/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Obstetrics/Gynecology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No