Device Classification Name |
screw, fixation, bone
|
510(k) Number |
K922788 |
Device Name |
BIOACTION LOW PROFILE SCREW SYSTEM |
Applicant |
ORTHOPAEDIC BIOSYSTEMS |
7725 EAST REDFIELD RD. |
UNIT 102 |
SCOTTSDALE,
AZ
85260
|
|
Applicant Contact |
CHIP KABRUD |
Correspondent |
ORTHOPAEDIC BIOSYSTEMS |
7725 EAST REDFIELD RD. |
UNIT 102 |
SCOTTSDALE,
AZ
85260
|
|
Correspondent Contact |
CHIP KABRUD |
Regulation Number | 888.3040
|
Classification Product Code |
|
Date Received | 06/09/1992 |
Decision Date | 03/12/1993 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|