Device Classification Name |
filler, bone void, calcium compound
|
510(k) Number |
K142463 |
Device Name |
Bio2 CLM BG Bioactive Scaffold |
Applicant |
Bio2 Technologies, Inc. |
12R Cabot Road |
Woburn,
MA
01801
|
|
Applicant Contact |
Janet Krevolin, PhD |
Correspondent |
Bio2 Technologies, Inc. |
12R Cabot Road |
Woburn,
MA
01801
|
|
Correspondent Contact |
Janet Krevolin, PhD |
Regulation Number | 888.3045
|
Classification Product Code |
|
Date Received | 09/02/2014 |
Decision Date | 12/18/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|