Device Classification Name |
filler, bone void, calcium compound
|
510(k) Number |
K110976 |
Device Name |
ORIGEN DBM WITH BIOACTIVE GLASS, NANOFUSE DBM |
Applicant |
NANOTHERAPEUTICS, INC. |
13859 PROGRESS BLVD, |
SUITE 300 |
ALACHUA,
FL
32615
|
|
Applicant Contact |
DENNIS TOMISAKA |
Correspondent |
NANOTHERAPEUTICS, INC. |
13859 PROGRESS BLVD, |
SUITE 300 |
ALACHUA,
FL
32615
|
|
Correspondent Contact |
DENNIS TOMISAKA |
Regulation Number | 888.3045
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 04/07/2011 |
Decision Date | 05/03/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|