Device Classification Name |
prosthesis, shoulder, hemi-, humeral, metallic uncemented
|
510(k) Number |
K961260 |
Device Name |
KIRSCHNER SHOLDERS WITH TITANIUM PLASMA SPRAY |
Applicant |
BIOMET, INC. |
AIRPORT INDUSTRIAL PARK |
WARSAW,
IN
46581
|
|
Applicant Contact |
PATRICIA S BERES |
Correspondent |
BIOMET, INC. |
AIRPORT INDUSTRIAL PARK |
WARSAW,
IN
46581
|
|
Correspondent Contact |
PATRICIA S BERES |
Regulation Number | 888.3690
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 04/02/1996 |
Decision Date | 04/02/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|