FIRST STEP UNICOMPARTMENTAL KNEE SYSTEM


Device Classification Name

prosthesis, knee, femorotibial, non-constrained, cemented, metal/polymer

510(k) Number K992287
Device Name FIRST STEP UNICOMPARTMENTAL KNEE SYSTEM
Applicant
HOWMEDICA OSTEONICS CORP.
59 route 17 south
allendale, 
NJ 
07401 -1677

Applicant Contact karen ariemma
Correspondent
HOWMEDICA OSTEONICS CORP.
59 route 17 south
allendale, 
NJ 
07401 -1677

Correspodent Contact karen ariemma
Regulation Number 888.3520
Classification Product Code
HSX  
Date Received 07/07/1999
Decision Date 11/16/1999
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No

Category: Uncategorized