Device Classification Name |
Filler, Bone Void, Calcium Compound
|
510(k) Number |
K092541 |
Device Name |
INTERFACE |
Applicant |
BIOSTRUCTURES |
26552 TAMPICO PLACE |
MISSION VIEJO,
CA
92691
|
|
Applicant Contact |
DAVE BALDING |
Correspondent |
BIOSTRUCTURES |
26552 TAMPICO PLACE |
MISSION VIEJO,
CA
92691
|
|
Correspondent Contact |
DAVE BALDING |
Regulation Number | 888.3045
|
Classification Product Code |
|
Date Received | 08/19/2009 |
Decision Date | 11/09/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|