Device Classification Name |
filler, bone void, calcium compound
|
510(k) Number |
K110561 |
Device Name |
FORTROSS BONE VOID FILLER |
Applicant |
PIONEER SURGICAL TECHNOLOGY |
11234 EL CAMINO REAL |
SUITE 200 |
SAN DIEGO,
CA
92130
|
|
Applicant Contact |
DAVID J COLLETTE |
Correspondent |
PIONEER SURGICAL TECHNOLOGY |
11234 EL CAMINO REAL |
SUITE 200 |
SAN DIEGO,
CA
92130
|
|
Correspondent Contact |
DAVID J COLLETTE |
Regulation Number | 888.3045
|
Classification Product Code |
|
Date Received | 02/28/2011 |
Decision Date | 04/29/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|