Device Classification Name |
Plate, Fixation, Bone
|
510(k) Number |
K120163 |
Device Name |
ACUTE INNOVATIONS BIOBRIDGE RESORBABLE PLATING SYSTEM |
Applicant |
ACUTE INNOVATIONS LLC |
21421 NW JACOBSON RD. |
SUITE 700 |
HILLSBORO,
OR
97124
|
|
Applicant Contact |
MARIAH KNIGHT |
Correspondent |
ACUTE INNOVATIONS LLC |
21421 NW JACOBSON RD. |
SUITE 700 |
HILLSBORO,
OR
97124
|
|
Correspondent Contact |
MARIAH KNIGHT |
Regulation Number | 888.3030
|
Classification Product Code |
|
Date Received | 01/19/2012 |
Decision Date | 02/17/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|