Device Classification Name |
Plate, Fixation, Bone
|
510(k) Number |
K981715 |
Device Name |
DISTAL RADIUS FRACTURE FIXATION PLATE |
Applicant |
AVANTA ORTHOPAEDICS, INC. |
9369 CARROLL PARK DRIVE, STE.A |
SAN DIEGO,
CA
92121
|
|
Applicant Contact |
LOUISE M FOCHT |
Correspondent |
AVANTA ORTHOPAEDICS, INC. |
9369 CARROLL PARK DRIVE, STE.A |
SAN DIEGO,
CA
92121
|
|
Correspondent Contact |
LOUISE M FOCHT |
Regulation Number | 888.3030
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 05/15/1998 |
Decision Date | 07/29/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|