Device Classification Name |
Screw, Fixation, Bone
|
510(k) Number |
K030388 |
Device Name |
IMPACT SUTURE ANCHOR. MODEL 433510 |
Applicant |
BIONX IMPLANTS, LTD. |
HERMIANKATU 6-8 L |
TAMPERE,
FI
FIN-33720
|
|
Applicant Contact |
TUIJA ANNALA |
Correspondent |
BIONX IMPLANTS, LTD. |
HERMIANKATU 6-8 L |
TAMPERE,
FI
FIN-33720
|
|
Correspondent Contact |
TUIJA ANNALA |
Regulation Number | 888.3040
|
Classification Product Code |
|
Date Received | 02/05/2003 |
Decision Date | 04/24/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|