Device Classification Name |
staple, fixation, bone
|
510(k) Number |
K003033 |
Device Name |
SCAPHIX, STAPLE, FIXATION, BONE |
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 |
|
Date Received | 09/28/2000 |
Decision Date | 05/30/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|