Device Classification Name |
Plate, Fixation, Bone
|
510(k) Number |
K031961 |
Device Name |
INION OTPS BIODEGRADABLE MESH PLATING SYSTEM |
Applicant |
INION LTD. |
LAAKARINKATU 2 |
TAMPERE,
FI
33520
|
|
Applicant Contact |
HANNA MARTTILA |
Correspondent |
INION LTD. |
LAAKARINKATU 2 |
TAMPERE,
FI
33520
|
|
Correspondent Contact |
HANNA MARTTILA |
Regulation Number | 888.3030
|
Classification Product Code |
|
Date Received | 06/25/2003 |
Decision Date | 03/01/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|