THE TRABECULAR METAL GLENOID-BIGLIANI/FLATOW THE COMPLETE SHOULDER SOLUTION, MODEL 4306


Device Classification Name

prosthesis, shoulder, non-constrained, metal/polymer cemented

510(k) Number K022377
Device Name THE TRABECULAR METAL GLENOID-BIGLIANI/FLATOW THE COMPLETE SHOULDER SOLUTION, MODEL 4306
Original Applicant
IMPLEX CORP.
80 commerce dr.
allendale, 
NJ 
07401 -1600

Original Contact robert a poggie
Regulation Number 888.3650
Classification Product Code
KWT  
Subsequent Product Code
KWS  
Date Received 07/22/2002
Decision Date 12/10/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls