Device Classification Name |
prosthesis, toe (metatarsophalangeal), joint, metal/polymer, semi-constrained
|
510(k) Number |
K072251 |
Device Name |
MERETE TOEMOBILE ANATOMICAL GREAT TOE RESURFACING 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 |
Classification Product Code |
|
Date Received | 08/13/2007 |
Decision Date | 05/08/2008 |
Decision |
Substantially Equivalent
(SESE) |
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|