Device Classification Name |
screw, fixation, bone
|
510(k) Number |
K910976 |
Device Name |
OREGON FIXATION SCREW |
Applicant |
ACUMED, INC. |
10950 S.W. 5TH ST. |
SUITE 170 |
BEAVERTON,
OR
97005
|
|
Applicant Contact |
RANDALL HUEBNER |
Correspondent |
ACUMED, INC. |
10950 S.W. 5TH ST. |
SUITE 170 |
BEAVERTON,
OR
97005
|
|
Correspondent Contact |
RANDALL HUEBNER |
Regulation Number | 888.3040
|
Classification Product Code |
|
Date Received | 03/07/1991 |
Decision Date | 01/13/1992 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|