Device Classification Name |
Filler, Bone Void, Calcium Compound
|
510(k) Number |
K053228 |
Device Name |
THERIGRAFT TCP PUTTY BONE VOID FILLER |
Applicant |
THERICS, LLC |
115 CAMPUS DR. |
PRINCETON,
NJ
08540
|
|
Applicant Contact |
SUNIL SAINI |
Correspondent |
THERICS, LLC |
115 CAMPUS DR. |
PRINCETON,
NJ
08540
|
|
Correspondent Contact |
SUNIL SAINI |
Regulation Number | 888.3045
|
Classification Product Code |
|
Date Received | 11/18/2005 |
Decision Date | 01/31/2006 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|