|
Device | REFLECTION CERAMIC ACETABULAR SYSTEM |
Generic Name | Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented |
Applicant | Smith & Nephew, Inc. 1450 Brooks Road Memphis, TN 38116 |
PMA Number | P030022 |
Date Received | 06/11/2003 |
Decision Date | 12/17/2004 |
Withdrawal Date | 08/31/2022 |
Product Code |
MRA |
Docket Number | 05M-0027 |
Notice Date | 01/21/2005 |
Advisory Committee |
Orthopedic |
Expedited Review Granted? | No |
Combination Product | No |
Predetermined Change Control Plan Authorized | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR THE REFLECTION CERAMIC ACETABULAR SYSTEM. THE DEVICE IS INDICATED FOR USE IN PATIENTS REQUIRING PRIMARY TOTAL HIP ARTHROPLASTY DUE TO NON-INFLAMMATORY ARTHRITIS (DEGENERATIVE JOINT DISEASE) SUCH AS OSTEOARTHRITIS, AVASCULAR NECROSIS, OR TRAUMATIC ARTHRITIS. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling Labeling Part 2 |
Post-Approval Study | Show Report Schedule and Study Progress |
Supplements: |
S040 S005 S006 S012 S013 S017 S014 S015 S016 S018 S019 S020 S021 S030 S031 S033 S032 S034 S035 S022 S023 S024 S025 S026 S027 S028 S029 S043 S038 S002 S003 S004 S001 S036 S037 S041 S042 S039 S008 S009 S010 S011 S045 S044 S047 S048 S049
|