Device Classification Name |
filler, bone void, calcium compound
|
510(k) Number |
K031319 |
Device Name |
OSTEO-G BONE VOID FILLER SYSTEM |
Applicant |
ASPINE USA, INC. |
4329 GRAYDON RD. |
SAN DIEGO,
CA
92130
|
|
Applicant Contact |
FLOYD G LARSON |
Correspondent |
ASPINE USA, INC. |
4329 GRAYDON RD. |
SAN DIEGO,
CA
92130
|
|
Correspondent Contact |
FLOYD G LARSON |
Regulation Number | 888.3045
|
Classification Product Code |
|
Date Received | 04/25/2003 |
Decision Date | 07/17/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|