Device Classification Name |
Bone Cement, Antibiotic
|
510(k) Number |
K161273 |
Device Name |
StageOne Disposable Cement Spacer Molds for Temporary Knee Prosthesis |
Applicant |
Biomet, Inc. |
56 East Bell Drive |
Warsaw,
IN
46581
|
|
Applicant Contact |
Carmen Albany |
Correspondent |
Biomet, Inc. |
56 East Bell Drive |
Warsaw,
IN
46581
|
|
Correspondent Contact |
Heidi Busz |
Regulation Number | 888.3027
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 05/05/2016 |
Decision Date | 01/25/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
Yes
|
Recalls |
CDRH Recalls
|
|
|