ORTHOSORB RESORBABLE PINS


Device Classification Name

pin, fixation, resorbable, hard tissue

510(k) Number K111077
Device Name ORTHOSORB RESORBABLE PINS
Applicant
DEPUY ORTHOPAEDICS, INC.
700 orthopaedic drive
warsaw, 
IN 
46581

Applicant Contact suzana otano
Correspondent
DEPUY ORTHOPAEDICS, INC.
700 orthopaedic drive
warsaw, 
IN 
46581

Correspodent Contact suzana otano
Regulation Number 888.3040
Classification Product Code
OVZ  
Date Received 04/18/2011
Decision Date 07/12/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No