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 |
Applicant |
IMPLEX CORP. |
80 COMMERCE DR. |
ALLENDALE,
NJ
07401 -1600
|
|
Applicant Contact |
ROBERT A POGGIE |
Correspondent |
IMPLEX CORP. |
80 COMMERCE DR. |
ALLENDALE,
NJ
07401 -1600
|
|
Correspondent Contact |
ROBERT A POGGIE |
Regulation Number | 888.3650
|
Classification Product Code |
|
Subsequent Product Code |
|
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
|
|
|