FDA.report

SMITH & NEPHEW, INC.

FDA Registration(s)

RegistrationFEINameStatusInitial importerExpiration yearAddress
10202791020279SMITH & NEPHEW, INC.1N2026-01-011450 BROOKS RD. MEMPHIS TN US 38116
30055516263005551626SMITH & NEPHEW, INC.1N2026-01-016409 E Holmes Rd Memphis TN US 38141
30073667903007282753Smith & Nephew, Inc.1Y2026-01-013303 E Holmes Rd Memphis TN US 38118
30087440623008744062Smith & Nephew, Inc.1N2026-01-017135 Goodlett Farms Pkwy Cordova TN US 38016
30100347803010034780Smith & Nephew, Inc.1Y2026-01-012225 Cedars Rd Ste A Lawrenceville GA US 30043
30385039323038503932Smith & Nephew, Inc.1N2026-01-014340 Swinnea Rd Memphis TN US 38118
30108866963010886696Smith & Nephew, Inc.1N2020-04-253510 Winchester Rd Memphis TN US 38118

Registered Device Listings

Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1257551345256376P150030R3 DELTA CERAMIC HIP SYSTEMMRA2016-10-17
551345256376P150030R3 DELTA CERAMIC HIP SYSTEMMRA2016-10-17
551377026204P030022REFLECTION CERAMIC ACETABULAR SYSTEMMRA2004-12-17
1257551377026204P030022REFLECTION CERAMIC ACETABULAR SYSTEMMRA2004-12-17
551607622273K994350NEER III TOTAL SHOULDER SYSTEMKWS2000-05-23
980011607622273K994350NEER III TOTAL SHOULDER SYSTEMKWS2000-05-23
1257551607622273K994350NEER III TOTAL SHOULDER SYSTEMKWS2000-05-23
1716491607622273K994350NEER III TOTAL SHOULDER SYSTEMKWS2000-05-23
3401451607622273K994350NEER III TOTAL SHOULDER SYSTEMKWS2000-05-23
551005360707K994143SMITH & NEPHEW EXTERNAL FIXATION SYSTEM [UNILATERAL (LINEAR) & MULTILATERAL (CIRCULAR) FIXATORS AND ACCESSORIES]JDW2000-02-18
980011005360707K994143SMITH & NEPHEW EXTERNAL FIXATION SYSTEM [UNILATERAL (LINEAR) & MULTILATERAL (CIRCULAR) FIXATORS AND ACCESSORIES]JDW2000-02-18
1257551005360707K994143SMITH & NEPHEW EXTERNAL FIXATION SYSTEM [UNILATERAL (LINEAR) & MULTILATERAL (CIRCULAR) FIXATORS AND ACCESSORIES]JDW2000-02-18
1716491005360707K994143SMITH & NEPHEW EXTERNAL FIXATION SYSTEM [UNILATERAL (LINEAR) & MULTILATERAL (CIRCULAR) FIXATORS AND ACCESSORIES]JDW2000-02-18
3401451005360707K994143SMITH & NEPHEW EXTERNAL FIXATION SYSTEM [UNILATERAL (LINEAR) & MULTILATERAL (CIRCULAR) FIXATORS AND ACCESSORIES]JDW2000-02-18
551974574317K993289SMITH & NEPHEW COMPRESSION HIP SCREW SYSTEM, INTRAMEDULLARY HIP SCREW SYSTEMKTT1999-12-20
980011974574317K993289SMITH & NEPHEW COMPRESSION HIP SCREW SYSTEM, INTRAMEDULLARY HIP SCREW SYSTEMKTT1999-12-20
1257551974574317K993289SMITH & NEPHEW COMPRESSION HIP SCREW SYSTEM, INTRAMEDULLARY HIP SCREW SYSTEMKTT1999-12-20
1716491974574317K993289SMITH & NEPHEW COMPRESSION HIP SCREW SYSTEM, INTRAMEDULLARY HIP SCREW SYSTEMKTT1999-12-20
3401451974574317K993289SMITH & NEPHEW COMPRESSION HIP SCREW SYSTEM, INTRAMEDULLARY HIP SCREW SYSTEMKTT1999-12-20
551143492620K993106SMITH & NEPHEW BONE PLATE SYSTEM (BONE PLATES, BONE SCREWS AND ACCESSORIES)HRS1999-12-09
980011143492620K993106SMITH & NEPHEW BONE PLATE SYSTEM (BONE PLATES, BONE SCREWS AND ACCESSORIES)HRS1999-12-09
1257551143492620K993106SMITH & NEPHEW BONE PLATE SYSTEM (BONE PLATES, BONE SCREWS AND ACCESSORIES)HRS1999-12-09
1716491143492620K993106SMITH & NEPHEW BONE PLATE SYSTEM (BONE PLATES, BONE SCREWS AND ACCESSORIES)HRS1999-12-09
3401451143492620K993106SMITH & NEPHEW BONE PLATE SYSTEM (BONE PLATES, BONE SCREWS AND ACCESSORIES)HRS1999-12-09
551785751982K992220RADIAL HEAD PROSTHESISKWI2000-02-25
980011785751982K992220RADIAL HEAD PROSTHESISKWI2000-02-25
1257551785751982K992220RADIAL HEAD PROSTHESISKWI2000-02-25
1716491785751982K992220RADIAL HEAD PROSTHESISKWI2000-02-25
3401451785751982K992220RADIAL HEAD PROSTHESISKWI2000-02-25
1257551808812632K991538OPERA CUPFLANGED ACETABULAR COMPONENTSJDI1999-06-03
980011808812632K991538OPERA CUPFLANGED ACETABULAR COMPONENTSJDI1999-06-03
551808812632K991538OPERA CUPFLANGED ACETABULAR COMPONENTSJDI1999-06-03
551818210685K991485SYNERGY POROUS SIZE 8 HIP STEMLPH1999-07-12
980011818210685K991485SYNERGY POROUS SIZE 8 HIP STEMLPH1999-07-12
1257551818210685K991485SYNERGY POROUS SIZE 8 HIP STEMLPH1999-07-12
1716491818210685K991485SYNERGY POROUS SIZE 8 HIP STEMLPH1999-07-12
3401451818210685K991485SYNERGY POROUS SIZE 8 HIP STEMLPH1999-07-12
1514781373223876K991383HYDROCISION DEBDRIDEMENT SYSTEMFQH2000-03-31
551989901421K991162BIOLOX ALUMINA CERAMIC FEMORAL HEADLZO2000-01-28
980011989901421K991162BIOLOX ALUMINA CERAMIC FEMORAL HEADLZO2000-01-28
1257551989901421K991162BIOLOX ALUMINA CERAMIC FEMORAL HEADLZO2000-01-28
551803429688K991026REFLECTION CROSSLINKED UHMWPE ACETABULAR COMPONENTSLPH1999-10-22
980011803429688K991026REFLECTION CROSSLINKED UHMWPE ACETABULAR COMPONENTSLPH1999-10-22
1257551803429688K991026REFLECTION CROSSLINKED UHMWPE ACETABULAR COMPONENTSLPH1999-10-22
1716491803429688K991026REFLECTION CROSSLINKED UHMWPE ACETABULAR COMPONENTSLPH1999-10-22
3401451803429688K991026REFLECTION CROSSLINKED UHMWPE ACETABULAR COMPONENTSLPH1999-10-22
551270696644K990666HYDROXYAPATITE (HA) REFLECTION ACETABULAR SHELL, HYDROXYAPATITE (HA) REFLECTION INTERFIT SHELLMEH1999-08-06
3401451270696644K990666HYDROXYAPATITE (HA) REFLECTION ACETABULAR SHELL, HYDROXYAPATITE (HA) REFLECTION INTERFIT SHELLMEH1999-08-06
980011270696644K990666HYDROXYAPATITE (HA) REFLECTION ACETABULAR SHELL, HYDROXYAPATITE (HA) REFLECTION INTERFIT SHELLMEH1999-08-06
1716491270696644K990666HYDROXYAPATITE (HA) REFLECTION ACETABULAR SHELL, HYDROXYAPATITE (HA) REFLECTION INTERFIT SHELLMEH1999-08-06
1257551270696644K990666HYDROXYAPATITE (HA) REFLECTION ACETABULAR SHELL, HYDROXYAPATITE (HA) REFLECTION INTERFIT SHELLMEH1999-08-06
551100766499K990369SYNERGY CEMENTED HIP STEMJDI1999-03-12
980011100766499K990369SYNERGY CEMENTED HIP STEMJDI1999-03-12
1257551100766499K990369SYNERGY CEMENTED HIP STEMJDI1999-03-12
1716491100766499K990369SYNERGY CEMENTED HIP STEMJDI1999-03-12
3401451100766499K990369SYNERGY CEMENTED HIP STEMJDI1999-03-12
551926793132K983942INTRAMEDULLARY NAIL SYSTEM, LOCKING SCREW, NAIL CAPJDS1998-12-04
980011926793132K983942INTRAMEDULLARY NAIL SYSTEM, LOCKING SCREW, NAIL CAPJDS1998-12-04
1257551926793132K983942INTRAMEDULLARY NAIL SYSTEM, LOCKING SCREW, NAIL CAPJDS1998-12-04
1716491926793132K983942INTRAMEDULLARY NAIL SYSTEM, LOCKING SCREW, NAIL CAPJDS1998-12-04
3401451926793132K983942INTRAMEDULLARY NAIL SYSTEM, LOCKING SCREW, NAIL CAPJDS1998-12-04
551298239724K983834ECHELON HIP STEMLPH1999-02-24
980011298239724K983834ECHELON HIP STEMLPH1999-02-24
1257551298239724K983834ECHELON HIP STEMLPH1999-02-24
1716491298239724K983834ECHELON HIP STEMLPH1999-02-24
3401451298239724K983834ECHELON HIP STEMLPH1999-02-24
3401451741822189K981847BIOLOX ALUMINA CERAMIC FEMORAL HEADLZO1998-07-17
1716491741822189K981847BIOLOX ALUMINA CERAMIC FEMORAL HEADLZO1998-07-17
1257551741822189K981847BIOLOX ALUMINA CERAMIC FEMORAL HEADLZO1998-07-17
980011741822189K981847BIOLOX ALUMINA CERAMIC FEMORAL HEADLZO1998-07-17
551741822189K981847BIOLOX ALUMINA CERAMIC FEMORAL HEADLZO1998-07-17
1514781966265438K981713CICANET WOUND CONTACT LAYER DRESSING - 2 X 3 IN. MODEL 59100600, CICANET WOUND CONTACT LAYER DRESSING - 4 X 5 IN. MODEL0MGP1998-07-31
551390826652K981529TITANIUM INTRAMEDULLARY NAIL, TITANIUM LOCKING SCREWJDS1998-07-09
980011390826652K981529TITANIUM INTRAMEDULLARY NAIL, TITANIUM LOCKING SCREWJDS1998-07-09
1257551390826652K981529TITANIUM INTRAMEDULLARY NAIL, TITANIUM LOCKING SCREWJDS1998-07-09
1716491390826652K981529TITANIUM INTRAMEDULLARY NAIL, TITANIUM LOCKING SCREWJDS1998-07-09
3401451390826652K981529TITANIUM INTRAMEDULLARY NAIL, TITANIUM LOCKING SCREWJDS1998-07-09
1514781558257663K973228STING SKIN PREP WIPE(59420600)/STING SKIN PREP SWAB (59420700)KMF1997-11-25
3401451646671095K971414ZIRCONIA PROZYR CERAMIC 12/14 GLOBAL TAPER (GT) FEMORAL HEADSLZO1997-07-16
1716491646671095K971414ZIRCONIA PROZYR CERAMIC 12/14 GLOBAL TAPER (GT) FEMORAL HEADSLZO1997-07-16
551646671095K971414ZIRCONIA PROZYR CERAMIC 12/14 GLOBAL TAPER (GT) FEMORAL HEADSLZO1997-07-16
980011646671095K971414ZIRCONIA PROZYR CERAMIC 12/14 GLOBAL TAPER (GT) FEMORAL HEADSLZO1997-07-16
1257551646671095K971414ZIRCONIA PROZYR CERAMIC 12/14 GLOBAL TAPER (GT) FEMORAL HEADSLZO1997-07-16
551234497942K970751HEIDELBERG EXTERNAL FIXATORJDW1997-04-16
980011234497942K970751HEIDELBERG EXTERNAL FIXATORJDW1997-04-16
1257551234497942K970751HEIDELBERG EXTERNAL FIXATORJDW1997-04-16
1716491234497942K970751HEIDELBERG EXTERNAL FIXATORJDW1997-04-16
3401451234497942K970751HEIDELBERG EXTERNAL FIXATORJDW1997-04-16
551252115402K970748TAYLOR SPATIAL FRAME EXTERNAL FIXATION SYSTEMKTT1997-05-09
980011252115402K970748TAYLOR SPATIAL FRAME EXTERNAL FIXATION SYSTEMKTT1997-05-09
1257551252115402K970748TAYLOR SPATIAL FRAME EXTERNAL FIXATION SYSTEMKTT1997-05-09
1716491252115402K970748TAYLOR SPATIAL FRAME EXTERNAL FIXATION SYSTEMKTT1997-05-09
3401451252115402K970748TAYLOR SPATIAL FRAME EXTERNAL FIXATION SYSTEMKTT1997-05-09
551043252042K970713COMPASS UNIVERSAL HINGEJDW1997-04-03
980011043252042K970713COMPASS UNIVERSAL HINGEJDW1997-04-03
1257551043252042K970713COMPASS UNIVERSAL HINGEJDW1997-04-03
551442246657K970351GLOBAL TAPER SPECTRON HIP STEMSJDI1997-02-28
980011442246657K970351GLOBAL TAPER SPECTRON HIP STEMSJDI1997-02-28
1257551442246657K970351GLOBAL TAPER SPECTRON HIP STEMSJDI1997-02-28
1716491442246657K970351GLOBAL TAPER SPECTRON HIP STEMSJDI1997-02-28
3401451442246657K970351GLOBAL TAPER SPECTRON HIP STEMSJDI1997-02-28
3401451500002751K970337HA GLOBAL TAPER (GT) TAPERED HIP STEMMEH1997-02-28
1716491500002751K970337HA GLOBAL TAPER (GT) TAPERED HIP STEMMEH1997-02-28
551500002751K970337HA GLOBAL TAPER (GT) TAPERED HIP STEMMEH1997-02-28
980011500002751K970337HA GLOBAL TAPER (GT) TAPERED HIP STEMMEH1997-02-28
1257551500002751K970337HA GLOBAL TAPER (GT) TAPERED HIP STEMMEH1997-02-28
3401451765971876K964163TRIMAX NAIL SYSTEMHSB1996-12-27
1716491765971876K964163TRIMAX NAIL SYSTEMHSB1996-12-27
1257551765971876K964163TRIMAX NAIL SYSTEMHSB1996-12-27
551765971876K964163TRIMAX NAIL SYSTEMHSB1996-12-27
980011765971876K964163TRIMAX NAIL SYSTEMHSB1996-12-27
3401451349038294K963509GLOBAL TAPER TAPERED HIP SYSTEM, GT SPECTRONLPH1997-01-27
1716491349038294K963509GLOBAL TAPER TAPERED HIP SYSTEM, GT SPECTRONLPH1997-01-27
1257551349038294K963509GLOBAL TAPER TAPERED HIP SYSTEM, GT SPECTRONLPH1997-01-27
980011349038294K963509GLOBAL TAPER TAPERED HIP SYSTEM, GT SPECTRONLPH1997-01-27
551349038294K963509GLOBAL TAPER TAPERED HIP SYSTEM, GT SPECTRONLPH1997-01-27
1257551385434597K963486REVISION HIP SYSTEMJDI1996-11-27
980011385434597K963486REVISION HIP SYSTEMJDI1996-11-27
551385434597K963486REVISION HIP SYSTEMJDI1996-11-27
1257551969379417K963255PROFIX PLUS TIBIAL INSERT, PROFIX PS PLUS TIBIAL INSERT, PROFIX P/S TIBIAL INSERTJWH1997-01-02

Product Codes Associated With Registrations

Product codeRegistration listing recordsLatest decision
JWH2302025-04-02
HRS1452025-02-19
LPH1362024-10-07
JDI912024-10-21
KTT882021-07-29
MEH662017-05-01
LZO632025-03-28
HSX602024-10-30
HSB592024-12-09
MBH482021-10-01
MBL462020-10-06
HWC452014-05-15
JDS442025-06-12
JDW412022-12-08
OLO332024-03-18
KWS322026-04-06
KWZ262017-06-19
NPJ232009-12-15
HAW212005-01-14
JDO182022-09-29
JDQ132024-03-13
OMP112016-08-04
KRO92015-07-28
KWL91994-04-25
LZY82023-07-19
LOD82015-03-05
KWY82003-01-23
KRR62005-05-31
GAT52013-10-30
HSD52012-09-07
KMF52010-02-23
MBF52007-05-18
HTY52004-07-30
KWI52000-02-25
JDJ51996-09-17
LXT51995-10-31
HSZ51994-09-06
MBV51983-11-29
JOL51983-09-29
LZN51979-06-27

PMA

R3™ DELTA CERAMIC ACETABULAR SYSTEM

2022-11-18

Smith & Nephew, Inc.7135 Goodlett Farms Parkwaycordova, TN 38016 PMA NumberP150030 Supplement NumberS028 Date Received10/25/2022 Decision Date11/18/2022 Product Code MRA  Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process C...

R3 DELTA CERAMIC ACETABULAR SYSTEM

2022-09-29

Smith & Nephew, Inc.7135 Goodlett Farms Parkwaycordova, TN 38016 PMA NumberP150030 Supplement NumberS027 Date Received08/31/2022 Decision Date09/29/2022 Product Code MRA  Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process C...

R3 Delta Ceramic Acetabular System

2022-09-21

Smith & Nephew, Inc.7135 Goodlett Farms Parkwaycordova, TN 38016 PMA NumberP150030 Supplement NumberS026 Date Received08/23/2022 Decision Date09/21/2022 Product Code MRA  Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process C...

R3 Delta Ceramic Acetabular System

2022-09-13

Smith & Nephew, Inc.7135 Goodlett Farms Parkwaycordova, TN 38016 PMA NumberP150030 Supplement NumberS025 Date Received08/16/2022 Decision Date09/13/2022 Product Code MRA  Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process C...

R3 Delta Ceramic Hip System

2022-09-01

Smith & Nephew, Inc.7135 Goodlett Farms Parkwaycordova, TN 38016 PMA NumberP150030 Supplement NumberS024 Date Received08/05/2022 Decision Date09/01/2022 Product Code MRA  Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process C...

Reflection Ceramic Hip System

2022-08-08

Smith & Nephew, Inc.1450 Brooks Roadmemphis, TN 38116 PMA NumberP030022 Supplement NumberS049 Date Received07/14/2022 Decision Date08/08/2022 Product Code MRA  Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Change - Man...

R3TM Delta Ceramic Acetabular System

2022-08-08

Smith & Nephew, Inc.1450 Brooks Roadmemphis, TN 38116 PMA NumberP150030 Supplement NumberS023 Date Received07/14/2022 Decision Date08/08/2022 Product Code MRA  Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Change - Man...

Reflection Ceramic Acetabular Hip System

2022-07-05

Smith & Nephew, Inc.1450 Brooks Roadmemphis, TN 38116 PMA NumberP030022 Supplement NumberS048 Date Received06/06/2022 Decision Date07/05/2022 Product Code MRA  Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Change - Man...

R3 Delta Ceramic Acetabular System

2022-06-21

Smith & Nephew, Inc.1450 Brooks Roadmemphis, TN 38116 PMA NumberP150030 Supplement NumberS022 Date Received05/23/2022 Decision Date06/21/2022 Product Code MRA  Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Change - Man...

Reflection Ceramic Hip System

2022-06-21

Smith & Nephew, Inc.1450 Brooks Roadmemphis, TN 38116 PMA NumberP030022 Supplement NumberS047 Date Received05/23/2022 Decision Date06/21/2022 Product Code MRA  Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Change - Man...

R3 Delta Ceramic Hip System, Reflection Ceramic Hip System

2022-05-17

Smith & Nephew, Inc.7135 Goodlett Farms Parkwaycordova, TN 38016 PMA NumberP150030 Supplement NumberS021 Date Received04/29/2022 Decision Date05/17/2022 Product Code MRA  Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process C...

R3™ Delta Ceramic Acetabular System

2022-05-03

Smith & Nephew, Inc.7135 Goodlett Farms Parkwaycordova, TN 38016 PMA NumberP150030 Supplement NumberS020 Date Received04/06/2022 Decision Date05/03/2022 Product Code MRA  Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process C...

R3 Delta Ceramic Hip System

2022-04-01

Smith & Nephew, Inc.7135 Goodlett Farms Parkwaycordova, TN 38016 PMA NumberP150030 Supplement NumberS019 Date Received03/07/2022 Decision Date04/01/2022 Product Code MRA  Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process C...

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PMN

200 records. Showing 1-40. Next

GUDID

NA

2026-03-10

Smith & Nephew, Inc.

NA

2026-02-20

Smith & Nephew, Inc.

NA

2026-02-20

Smith & Nephew, Inc.

NA

2026-02-20

Smith & Nephew, Inc.

NA

2026-02-20

Smith & Nephew, Inc.

NA

2026-02-20

Smith & Nephew, Inc.

NA

2026-02-20

Smith & Nephew, Inc.

EVOS

2025-12-23

Smith & Nephew, Inc.

NA

2025-12-22

Smith & Nephew, Inc.

NA

2025-12-22

Smith & Nephew, Inc.

NA

2025-12-22

Smith & Nephew, Inc.

NA

2025-12-22

Smith & Nephew, Inc.

NA

2025-12-22

Smith & Nephew, Inc.

NA

2025-12-22

Smith & Nephew, Inc.

N/A

2025-12-15

Smith & Nephew, Inc.

EVOS

2025-12-12

Smith & Nephew, Inc.

EVOS

2025-12-12

Smith & Nephew, Inc.

EVOS

2025-12-12

Smith & Nephew, Inc.

EVOS

2025-12-12

Smith & Nephew, Inc.

EVOS

2025-12-12

Smith & Nephew, Inc.

EVOS

2025-12-12

Smith & Nephew, Inc.

EVOS

2025-12-12

Smith & Nephew, Inc.

EVOS

2025-12-12

Smith & Nephew, Inc.

200 records. Showing 1-40. Next