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Device | R3 DELTA CERAMIC HIP 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 | P150030 |
Date Received | 08/20/2015 |
Decision Date | 10/17/2016 |
Product Code |
MRA |
Docket Number | 16M-3430 |
Notice Date | 10/20/2016 |
Advisory Committee |
Orthopedic |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for the R3TM delta Ceramic Acetabular System. This device is indicated for use in skeletally mature 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: |
S001 S002 S007 S020 S021 S022 S013 S014 S015 S016 S017 S033 S036 S003 S004 S005 S006 S008 S024 S025 S026 S027 S009 S010 S011 S034 S029 S030 S031 S032 S028 S023 S019 S018 S038 S039 S037 S035 |