COBREX HIP STEM, MODEL 01-128-XXXXX


Device Classification Name

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

510(k) Number K991869
Device Name COBREX HIP STEM, MODEL 01-128-XXXXX
Applicant
IMPLEX CORP.
80 commerce dr.
allendale, 
NJ 
07401 -1600

Applicant Contact robert poggie
Correspondent
IMPLEX CORP.
80 commerce dr.
allendale, 
NJ 
07401 -1600

Correspodent Contact robert poggie
Regulation Number 888.3350
Classification Product Code
JDI  
Date Received 06/01/1999
Decision Date 07/14/1999
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Abbreviated
Reviewed by Third Party No

Combination Product

No