Device Classification Name |
screw, fixation, bone
|
510(k) Number |
K932027 |
Device Name |
OREGON FIXATION SYSTEM INTERFERENCE SCREW |
Applicant |
ACUMED, INC. |
10950 S.W. 5TH ST. |
SUITE 170 |
BEAVERTON,
OR
97005
|
|
Applicant Contact |
GENE CONRAD |
Correspondent |
ACUMED, INC. |
10950 S.W. 5TH ST. |
SUITE 170 |
BEAVERTON,
OR
97005
|
|
Correspondent Contact |
GENE CONRAD |
Regulation Number | 888.3040
|
Classification Product Code |
|
Date Received | 04/26/1993 |
Decision Date | 02/23/1994 |
Decision |
SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS
(SN) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|