Device Classification Name |
cement, bone, vertebroplasty
|
510(k) Number |
K123942 |
Device Name |
STRYKER IVAS BALLOON CATHETER |
Applicant |
STRYKER CORPORATION |
4100 E. MILHAM AVE |
KALAMAZOO,
MI
49001
|
|
Applicant Contact |
CHRISTINA MCKEE |
Correspondent |
STRYKER CORPORATION |
4100 E. MILHAM AVE |
KALAMAZOO,
MI
49001
|
|
Correspondent Contact |
CHRISTINA MCKEE |
Regulation Number | 888.3027
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 12/20/2012 |
Decision Date | 04/03/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|