Device Classification Name |
filler, bone void, calcium compound
|
510(k) Number |
K101860 |
Device Name |
NOVABONE PUTTY- BIOACTIVE SYNTHETIC BONE GRAFT |
Applicant |
NovaBone Products, LLC |
13631 PROGRESS BLVD |
SUITE 600 |
ALACHUA,
FL
32615
|
|
Applicant Contact |
DAVID M GALSSER |
Correspondent |
NovaBone Products, LLC |
13631 PROGRESS BLVD |
SUITE 600 |
ALACHUA,
FL
32615
|
|
Correspondent Contact |
DAVID M GALSSER |
Regulation Number | 888.3045
|
Classification Product Code |
|
Date Received | 07/02/2010 |
Decision Date | 09/01/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|