Device Classification Name |
Screw, Fixation, Bone
|
510(k) Number |
K012000 |
Device Name |
1.5MM BONE FIXATION KIT |
Applicant |
BIONX IMPLANTS, LTD. |
P.O. BOX 3 |
HERMINKATU 6-8L |
TAMPERE,
FI
SP-33721
|
|
Applicant Contact |
TUIJA ANNALA |
Correspondent |
BIONX IMPLANTS, LTD. |
P.O. BOX 3 |
HERMINKATU 6-8L |
TAMPERE,
FI
SP-33721
|
|
Correspondent Contact |
TUIJA ANNALA |
Regulation Number | 888.3040
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 06/27/2001 |
Decision Date | 07/18/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|