ALTA CFX IM ROD SYSTEM


Device Classification Name

rod, fixation, intramedullary and accessories

510(k) Number K960524
Device Name ALTA CFX IM ROD SYSTEM
Applicant
HOWMEDICA CORP.
359 veterans blvd.
rutherford, 
NJ 
07070

Applicant Contact frank maas
Correspondent
HOWMEDICA CORP.
359 veterans blvd.
rutherford, 
NJ 
07070

Correspodent Contact frank maas
Regulation Number 888.3020
Classification Product Code
HSB  
Date Received 02/05/1996
Decision Date 03/22/1996
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No