HOFFMANN II EXTERNAL FIXATION SYSTEM


codes

Device Classification Name

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

510(k) Number K000957
Device Name HOFFMANN II EXTERNAL FIXATION SYSTEM
Original Applicant
HOWMEDICA OSTEONICS CORP.
59 route 17 south
allendale, 
NJ 
07401 -1677

Original Contact karen ariemma
Regulation Number 888.3030
Classification Product Code
LXT  
Date Received 03/24/2000
Decision Date 05/23/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

Type Traditional
Reviewed by Third Party No

Combination Product

No