DEPUY MITEK MILAGRO INTERFERENCE SCREW MODEL 231803, 231804, 231807, 231809


Device Classification Name

fastener, fixation, biodegradable, soft tissue

510(k) Number K103831
Device Name DEPUY MITEK MILAGRO INTERFERENCE SCREW MODEL 231803, 231804, 231807, 231809
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 888.3030
Classification Product Code
MAI  
Subsequent Product Code
HWC  
Date Received 12/30/2010
Decision Date 07/21/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No