6-8MM X 30 MM INTRAFIX PEEK TAPERED SCREW 7-9MM X 30MM INTRAFIX PEEK TAPERED SCREW 8-10MM X 30 MM INTRAFIX PEEK TAPERED


Device Classification Name

fastener, fixation, nondegradable, soft tissue

510(k) Number K122123
Device Name 6-8MM X 30 MM INTRAFIX PEEK TAPERED SCREW 7-9MM X 30MM INTRAFIX PEEK TAPERED SCREW 8-10MM X 30 MM INTRAFIX PEEK TAPERED
Applicant
DEPUY MITEK INC., A JOHNSON AND JOHNSON COMPANY
325 paramount drive
raynham, 
MA 
02767

Applicant Contact julie vafides
Correspondent
DEPUY MITEK INC., A JOHNSON AND JOHNSON COMPANY
325 paramount drive
raynham, 
MA 
02767

Correspodent Contact julie vafides
Regulation Number 888.3040
Classification Product Code
MBI  
Date Received 07/18/2012
Decision Date 10/02/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No