Device Classification Name |
prosthesis, shoulder, semi-constrained, metal/polymer cemented
|
510(k) Number |
K990598 |
Device Name |
OSTEONICS SOLAR SHOULDER HUMERAL BEARING HEAD |
Applicant |
HOWMEDICA OSTEONICS CORP. |
59 ROUTE 17 SOUTH |
ALLENDALE,
NJ
07401 -1677
|
|
Applicant Contact |
MARYBETH NAUGHTON |
Correspondent |
HOWMEDICA OSTEONICS CORP. |
59 ROUTE 17 SOUTH |
ALLENDALE,
NJ
07401 -1677
|
|
Correspondent Contact |
MARYBETH NAUGHTON |
Regulation Number | 888.3660
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 02/24/1999 |
Decision Date | 03/15/1999 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|