Device Classification Name |
Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
|
510(k) Number |
K911902 |
Device Name |
TEMPERLITE(TM) SAW BLADE |
Applicant |
SIERRA SURGICAL, INC. |
11315 SUNRISE GOLD CIRCLE, |
SUITE L |
RANCHO CORDOVA,
CA
95742
|
|
Applicant Contact |
REBECCA ANDERSEN |
Correspondent |
SIERRA SURGICAL, INC. |
11315 SUNRISE GOLD CIRCLE, |
SUITE L |
RANCHO CORDOVA,
CA
95742
|
|
Correspondent Contact |
REBECCA ANDERSEN |
Regulation Number | 888.3690
|
Classification Product Code |
|
Date Received | 04/26/1991 |
Decision Date | 06/28/1991 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|