Device Classification Name |
Filler, Bone Void, Calcium Compound
|
510(k) Number |
K073341 |
Device Name |
GENEX PUTTY |
Applicant |
BIOCOMPOSITES LTD. |
KEELE SCIENCE PARK |
KEELE, STAFFORDSHIRE,
GB
ST5 5NL
|
|
Applicant Contact |
SIMON FITZER |
Correspondent |
BIOCOMPOSITES LTD. |
KEELE SCIENCE PARK |
KEELE, STAFFORDSHIRE,
GB
ST5 5NL
|
|
Correspondent Contact |
SIMON FITZER |
Regulation Number | 888.3045
|
Classification Product Code |
|
Date Received | 11/28/2007 |
Decision Date | 07/09/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|