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Smith & Nephew, Inc.

159 FDA 510(k) clearances · PMA applicant

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RecordFirmDate
Ascension MCP (P000057/S013)Smith & Nephew, Inc.2025-12-31
ASCENSION MCP (P000057/S014)Smith & Nephew, Inc.2025-08-05
R3™ Delta Ceramic Acetabular System (P150030/S049)Smith & Nephew, Inc.2025-04-17
R3 DELTA CERAMIC HIP SYSTEM (P150030/S048)Smith & Nephew, Inc.2025-03-03
R3 Delta Ceramic Hip System (P150030/S045)Smith & Nephew, Inc.2025-02-28
R3™ Delta Ceramic Acetabular System (P150030/S047)Smith & Nephew, Inc.2025-02-21
R3™ Delta Ceramic Acetabular System (P150030/S046)Smith & Nephew, Inc.2025-01-16
BIRMINGHAM HIP™ RESURFACING (BHR) SYSTEM (P040033/S039)Smith & Nephew, Inc.2025-01-10
R3TM delta Ceramic Acetabular System (P150030/S043)Smith & Nephew, Inc.2024-09-13
R3TM DELTA CERAMIC ACETABULAR SYSTEM (P150030/S044)Smith & Nephew, Inc.2024-09-10
R3 Delta Ceramic Hip System, and POLARSTEM PMA Auxiliary Products (P150030/S042)Smith & Nephew, Inc.2024-08-30
R3 DELTA Ceramic Hip System (P150030/S041)Smith & Nephew, Inc.2024-07-23
R3 DELTA CERAMIC ACETABULAR SYSTEM (P150030/S040)Smith & Nephew, Inc.2024-06-27
R3 Delta Ceramic Hip System (P150030/S036)Smith & Nephew, Inc.2024-04-29
Ascension MCP (P000057/S012)Smith & Nephew, Inc.2024-03-20
R3™ Delta Ceramic Hip System (P150030/S039)Smith & Nephew, Inc.2024-03-20
R3 Delta Ceramic Hip System (P150030/S037)Smith & Nephew, Inc.2024-01-19
Birmingham Hip Resurfacing (BHR) System (P040033/S038)Smith & Nephew, Inc.2024-01-19
R3 Delta Ceramic Hip System (P150030/S038)Smith & Nephew, Inc.2023-12-13
R3 DELTA CERAMIC HIP SYSTEM (P150030/S035)Smith & Nephew, Inc.2023-08-11
R3 Delta Ceramic Hip System (P150030/S031)Smith & Nephew, Inc.2023-07-28
R3 DELTA CERAMIC HIP SYSTEM (P150030/S034)Smith & Nephew, Inc.2023-07-11
R3 Delta Ceramic Hip System (P150030/S033)Smith & Nephew, Inc.2023-06-20
R3 DELTA CERAMIC HIP SYSTEM (P150030/S032)Smith & Nephew, Inc.2023-03-30
Birmingham Hip Resurfacing (BHR) System (P040033/S037)Smith & Nephew, Inc.2023-02-22
R3 DELTA CERAMIC HIP SYSTEM (P150030/S029)Smith & Nephew, Inc.2023-02-12
R3 DELTA CERAMIC HIP SYSTEM (P150030/S030)Smith & Nephew, Inc.2023-02-12
R3™ DELTA CERAMIC ACETABULAR SYSTEM (P150030/S028)Smith & Nephew, Inc.2022-11-18
R3 DELTA CERAMIC ACETABULAR SYSTEM (P150030/S027)Smith & Nephew, Inc.2022-09-29
R3 Delta Ceramic Acetabular System (P150030/S026)Smith & Nephew, Inc.2022-09-21
R3 Delta Ceramic Acetabular System (P150030/S025)Smith & Nephew, Inc.2022-09-13
R3TM delta Ceramic Acetabular System (P150030/S014)Smith & Nephew, Inc.2022-09-09
R3 Delta Ceramic Hip System (P150030/S024)Smith & Nephew, Inc.2022-09-01
R3TM Delta Ceramic Acetabular System (P150030/S023)Smith & Nephew, Inc.2022-08-08
Reflection Ceramic Hip System (P030022/S049)Smith & Nephew, Inc.2022-08-08
Reflection Ceramic Acetabular Hip System (P030022/S048)Smith & Nephew, Inc.2022-07-05
Reflection Ceramic Hip System (P030022/S047)Smith & Nephew, Inc.2022-06-21
R3 Delta Ceramic Acetabular System (P150030/S022)Smith & Nephew, Inc.2022-06-21
Birmingham Hip Resurfacing (BHR) System (P040033/S036)Smith & Nephew, Inc.2022-05-19
R3 Delta Ceramic Hip System, Reflection Ceramic Hip System (P150030/S021)Smith & Nephew, Inc.2022-05-17
R3™ Delta Ceramic Acetabular System (P150030/S020)Smith & Nephew, Inc.2022-05-03
R3 Delta Ceramic Hip System (P150030/S019)Smith & Nephew, Inc.2022-04-01
R3TM delta Ceramic Acetabular System (P150030/S016)Smith & Nephew, Inc.2022-03-04
R3 Delta Ceramic Hip System (P150030/S018)Smith & Nephew, Inc.2021-12-20
R3 DELTA CERAMIC HIP SYSTEM (P150030/S017)Smith & Nephew, Inc.2021-12-08
R3 Delta Ceramic Hip System (P150030/S013)Smith & Nephew, Inc.2021-11-10
R3 DELTA CERAMIC HIP SYSTEM (P150030/S015)Smith & Nephew, Inc.2021-11-09
R3 Delta Ceramic Hip System (P150030/S009)Smith & Nephew, Inc.2021-06-30
R3 Delta Ceramic Acetabular System (P150030/S010)Smith & Nephew, Inc.2021-06-30
R3 Delta Ceramic Acetabular System (P150030/S011)Smith & Nephew, Inc.2021-06-29
R3 Biolox delta Ceramic Acetabular System (P150030/S008)Smith & Nephew, Inc.2020-08-21
R3 delta Ceramic Acetabular System (P150030/S007)Smith & Nephew, Inc.2019-06-07
Ascension MCP (P000057/S011)Smith & Nephew, Inc.2019-03-05
R3 delta Ceramic Acetabular System (P150030/S006)Smith & Nephew, Inc.2019-02-19
R3 delta Ceramic Acetabular System (P150030/S005)Smith & Nephew, Inc.2018-12-07
ASCENSION MCP FINGER IMPLANT (P000057/S008)Smith & Nephew, Inc.2018-09-10
Ascension MCP (P000057/S010)Smith & Nephew, Inc.2018-06-29
REFLECTION CERAMIC ACETABULAR HIP SYSTEM (RCHS) (P030022/S039)Smith & Nephew, Inc.2018-03-20
Birmingham Hip Resurfacing (BHR) System (P040033/S033)Smith & Nephew, Inc.2018-03-02
BIRMINGHAM HIP RESURFACING (BHR) SYSTEM (P040033/S031)Smith & Nephew, Inc.2018-02-22
Birmingham Hip Resurfacing System (P040033/S032)Smith & Nephew, Inc.2017-12-20
REFLECTION Ceramic Acetabular Hip System (P030022/S045)Smith & Nephew, Inc.2017-12-20
R3 DELTA Ceramic Hip System (P150030/S004)Smith & Nephew, Inc.2017-12-20
R3 Delta Ceramic Acetabular System (P150030/S003)Smith & Nephew, Inc.2017-11-30
RCHS Ceramic Liners and Shells (P030022/S044)Smith & Nephew, Inc.2017-08-17
ASCENSION MCP (P000057/S009)Smith & Nephew, Inc.2017-08-04
REFLECTION Ceramic Acetabular Hip System (RCHS) (P030022/S043)Smith & Nephew, Inc.2017-06-02
R3 DELTA Ceramic Hip System (P150030/S002)Smith & Nephew, Inc.2017-06-02
REFLECTION CERAMIC ACETABULAR SYSTEM (P030022/S042)Smith & Nephew, Inc.2017-01-12
R3 DELTA CERAMIC HIP SYSTEM (P150030/S001)Smith & Nephew, Inc.2016-12-21
BIRMINGHAM HIP SYSTEM (BHR) (P040033/S030)Smith & Nephew, Inc.2016-12-21
REFLECTION CERAMIC ACETABULAR HIP SYSTEM (RCHS) (P030022/S038)Smith & Nephew, Inc.2016-12-21
REFLECTION CERAMIC ACETABULAR SYSTEM (P030022/S041)Smith & Nephew, Inc.2016-12-08
REFLECTION CERAMIC ACETABULAR SYSTEM (P030022/S040)Smith & Nephew, Inc.2016-11-09
R3 DELTA CERAMIC HIP SYSTEM (P150030)Smith & Nephew, Inc.2016-10-17
REFLECTION CERAMIC Acetabular Hip SYSTEM (RCHS) (P030022/S037)Smith & Nephew, Inc.2016-10-04
REFLECTION CERAMIC ACETABULAR HIP SYSTEM (P030022/S036)Smith & Nephew, Inc.2016-07-22
ANTHOLOGY FEMORAL STEMS (P030022/S033)Smith & Nephew, Inc.2016-06-08
BIRMINGHAM HIP RESURFACING (BHR) SYSTEM (P040033/S029)Smith & Nephew, Inc.2016-01-28
REFLECTION CERAMIC ACETABULAR HIP SYSTEM (RCHS) (P030022/S035)Smith & Nephew, Inc.2016-01-28
REFLECTION CERAMIC ACETABULAR HIPS SYSTEM (RCHS) (P030022/S034)Smith & Nephew, Inc.2015-12-17
BIRMINGHAM HIP RESURFACING (BHR) SYSTEM (P040033/S024)Smith & Nephew, Inc.2015-12-11
REFLECTION CERAMIC ACETABULAR HIP SYSTEM (RCHS) (P030022/S032)Smith & Nephew, Inc.2015-09-25
BIRMINGHAM HIP RESURFACING (BHR) SYSTEM (P040033/S028)Smith & Nephew, Inc.2015-08-10
R3 ACETABULAR SHELLS (P030022/S031)Smith & Nephew, Inc.2014-10-17
REFLECTION CERAMIC ACETABULAR HIP SYSTEM (P030022/S027)Smith & Nephew, Inc.2014-09-05
BIRMINGHAM HIP RESURFACING SYSTEM (P040033/S025)Smith & Nephew, Inc.2014-08-12
BIRMINGHAM HIP RESURFACING (BHR) SYSTEM (P040033/S027)Smith & Nephew, Inc.2014-07-30
BIRMINGHAM HIP RESURFACING (BHR) SYSTEM (P040033/S026)Smith & Nephew, Inc.2014-06-17
REFLECTION CERAMIC HIP SYSTEM (RCHS) (P030022/S030)Smith & Nephew, Inc.2014-05-30
BIRMINGHAM HIP RESURFACING SYSTEM (P040033/S023)Smith & Nephew, Inc.2014-03-06
ASCENSION MCP (P000057/S007)Smith & Nephew, Inc.2014-03-06
REFLECTION CERAMIC ACETABULAR HIP SYSTEM (RCHS) (P030022/S028)Smith & Nephew, Inc.2014-01-13
REFECTION CERAMIC HIP SYSTEM (RCHS) (P030022/S029)Smith & Nephew, Inc.2014-01-13
REFLECTION CERAMIC HIP SYSTEM (P030022/S026)Smith & Nephew, Inc.2013-10-25
REFLECTION CERAMIC HIP SYSTEM (P030022/S025)Smith & Nephew, Inc.2013-08-30
REFLECTION CERAMIC HIP SYSTEM (RCHS) (P030022/S024)Smith & Nephew, Inc.2013-08-06
REFLECTION CERAMIC HIP SYSTEM (P030022/S023)Smith & Nephew, Inc.2013-08-01
BIRMINGHAM HIP RESURFACING (BHR) SYSTEM (P040033/S018)Smith & Nephew, Inc.2012-09-11
REFLECTION CERAMIC ACETABULAR HIP SYSTEM (RCHS) (P030022/S022)Smith & Nephew, Inc.2012-09-06
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