Device Classification Name |
rod, fixation, intramedullary and accessories
|
510(k) Number |
K101939 |
Device Name |
OSTEOBRIDGE IKA INTRAMEDULLARY KNEE ARTHRODESIS ROD FIXATION SYSTEM |
Applicant |
MERETE MEDICAL GMBH |
49 PURCHASE STREET |
RYE,
NY
10580
|
|
Applicant Contact |
DONNA COLEMAN |
Correspondent |
MERETE MEDICAL GMBH |
49 PURCHASE STREET |
RYE,
NY
10580
|
|
Correspondent Contact |
DONNA COLEMAN |
Regulation Number | 888.3020
|
Classification Product Code |
|
Date Received | 07/12/2010 |
Decision Date | 10/07/2010 |
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
|
|
|