THE IMPLEX MODULAR ELLIPTICAL POROUS ACETABULAR CUP, MODEL XX-2YY-ZZZZ


Device Classification Name

prosthesis, hip, semi-constrained, metal/polymer, cemented

510(k) Number K992409
Device Name THE IMPLEX MODULAR ELLIPTICAL POROUS ACETABULAR CUP, MODEL XX-2YY-ZZZZ
Applicant
IMPLEX CORP.
80 commerce dr.
allendale, 
NJ 
07401 -1600

Applicant Contact john schlago
Correspondent
IMPLEX CORP.
80 commerce dr.
allendale, 
NJ 
07401 -1600

Correspodent Contact john schlago
Regulation Number 888.3350
Classification Product Code
JDI  
Date Received 07/20/1999
Decision Date 10/08/1999
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No