ULTIMAX HAIG II NAIL SYSTEM


Device Classification Name

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

510(k) Number K991889
Device Name ULTIMAX HAIG II NAIL SYSTEM
Applicant
ENCORE ORTHOPEDICS, INC.
9800 metric blvd.
austin, 
TX 
78758

Applicant Contact debbie de los santos
Correspondent
ENCORE ORTHOPEDICS, INC.
9800 metric blvd.
austin, 
TX 
78758

Correspodent Contact debbie de los santos
Regulation Number 888.3030
Classification Product Code
LXT  
Date Received 06/03/1999
Decision Date 08/12/1999
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No