Device Classification Name |
Filler, Bone Void, Calcium Compound
|
510(k) Number |
K120279 |
Device Name |
NANOFUSE DBM |
Applicant |
NANOTHERAPEUTICS |
13859 PROGRESS BLVD |
SUITE 300 |
ALACHUA,
FL
32615
|
|
Applicant Contact |
GREGG RITTER |
Correspondent |
NANOTHERAPEUTICS |
13859 PROGRESS BLVD |
SUITE 300 |
ALACHUA,
FL
32615
|
|
Correspondent Contact |
GREGG RITTER |
Regulation Number | 888.3045
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 01/30/2012 |
Decision Date | 04/06/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|