ORTHOFIX MODULSYSTEM


Device Classification Name

pin, fixation, threaded

510(k) Number K955848
Device Name ORTHOFIX MODULSYSTEM
Applicant
ORTHOFIX, INC.
12300 twinbrook pkwy.
suite 625
rockville, 
MD 
20852

Applicant Contact robert l sheridan
Correspondent
ORTHOFIX, INC.
12300 twinbrook pkwy.
suite 625
rockville, 
MD 
20852

Correspodent Contact robert l sheridan
Regulation Number 888.3040
Classification Product Code
JDW  
Date Received 12/27/1995
Decision Date 03/20/1996
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls