Device Classification Name |
Plate, Fixation, Bone
|
510(k) Number |
K113109 |
Device Name |
STRYKER RESORBABLE FIXATION SYSTEM |
Applicant |
Stryker |
750 TRADE CENTER WAY |
STE 200 |
PORAGE,
MI
49002
|
|
Applicant Contact |
Manish Patel |
Correspondent |
Stryker |
750 TRADE CENTER WAY |
STE 200 |
PORAGE,
MI
49002
|
|
Correspondent Contact |
Manish Patel |
Regulation Number | 888.3030
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 10/20/2011 |
Decision Date | 12/23/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|