Device Classification Name |
Cement, Bone, Vertebroplasty
|
510(k) Number |
K150582 |
Device Name |
Vertaplex® High Viscosity (HV) Radiopaque Bone Cement |
Applicant |
STRYKER CORPORATION |
4100 E. MILHAM AVENUE |
KALAMAZOO,
MI
49001
|
|
Applicant Contact |
KRISTI ASHTON |
Correspondent |
STRYKER CORPORATION |
4100 E. MILHAM AVENUE |
KALAMAZOO,
MI
49001
|
|
Correspondent Contact |
KRISTI ASHTON |
Regulation Number | 888.3027
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 03/09/2015 |
Decision Date | 06/12/2015 |
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
|
|
|