Device Classification Name |
rod, fixation, intramedullary and accessories
|
510(k) Number |
K021008 |
Device Name |
ADVANCED ORTHOPAEDIC SOLUTIONS TROCHANTERIC NAIL |
Applicant |
ADVANCED ORTHOPAEDIC SOLUTIONS, INC. |
333 WEST 6TH ST., SUITE 202 |
SAN PEDRO,
CA
90731
|
|
Applicant Contact |
PAUL DONER |
Correspondent |
ADVANCED ORTHOPAEDIC SOLUTIONS, INC. |
333 WEST 6TH ST., SUITE 202 |
SAN PEDRO,
CA
90731
|
|
Correspondent Contact |
PAUL DONER |
Regulation Number | 888.3020
|
Classification Product Code |
|
Date Received | 03/28/2002 |
Decision Date | 06/20/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|