Device Classification Name |
screw, fixation, bone
|
510(k) Number |
K123672 |
Device Name |
INION FREEDOMSCREW (ALTERNATIVE MARKETING NAME: INION OTPS FREEDOMSCREW) |
Applicant |
INION OY |
LAAKARINKATU 2 |
TAMPERE,
FI
33520
|
|
Applicant Contact |
KATI MARTTINEN |
Correspondent |
INION OY |
LAAKARINKATU 2 |
TAMPERE,
FI
33520
|
|
Correspondent Contact |
KATI MARTTINEN |
Regulation Number | 888.3040
|
Classification Product Code |
|
Date Received | 11/29/2012 |
Decision Date | 02/27/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|