Device Classification Name |
Screw, Fixation, Bone
|
510(k) Number |
K020266 |
Device Name |
INION CPS BSSO SCREW |
Applicant |
INION LTD. |
LAAKARINKATU 2 |
TAMPERE,
FI
FIN-33520
|
|
Applicant Contact |
HANNA MARTTILA |
Correspondent |
INION LTD. |
Laakarinkatu 2 |
Tampere,
FI
FIN-33520
|
|
Correspondent Contact |
Kati Marttinen |
Regulation Number | 888.3040
|
Classification Product Code |
|
Date Received | 01/25/2002 |
Decision Date | 02/22/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|