Device Classification Name |
prosthesis, shoulder, hemi-, humeral, metallic uncemented
|
510(k) Number |
K905580 |
Device Name |
TOTAL SHOULDER PROSTHESIS POLYETHYLENE GLENOIND CO |
Applicant |
EXACTECH, INC. |
2210 N.W. 28TH ST. |
GAINESVILLE,
FL
32605
|
|
Applicant Contact |
WILLIAM PETTY |
Correspondent |
EXACTECH, INC. |
2210 N.W. 28TH ST. |
GAINESVILLE,
FL
32605
|
|
Correspondent Contact |
WILLIAM PETTY |
Regulation Number | 888.3690
|
Classification Product Code |
|
Date Received | 12/12/1990 |
Decision Date | 03/12/1991 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|