HOFFMANN 3 MODULAR EXTERNAL FIXATION SYSTEM


Device Classification Name

appliance, fixation, nail/blade/plate combination, multiple component

510(k) Number K111786
Device Name HOFFMANN 3 MODULAR EXTERNAL FIXATION SYSTEM
Applicant
STRYKER CORP.
325 corporate drive
mahwah, 
NJ 
07430

Applicant Contact estela celi
Correspondent
STRYKER CORP.
325 corporate drive
mahwah, 
NJ 
07430

Correspodent Contact estela celi
Regulation Number 888.3030
Classification Product Code
KTT  
Date Received 06/24/2011
Decision Date 01/26/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No