SMITH & NEPHEW INC.

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
1219602	1219602	SMITH & NEPHEW INC.	1	N	2026-01-01	ENDOSCOPY 120 FORBES BLVD. SUITE 150 / 130 FORBES BLVD. MANSFIELD MA US 02048
1643264	1643264	SMITH & NEPHEW INC.	1	Y	2026-01-01	ENDOSCOPY 76 S. MERIDIAN AVE. OKLAHOMA CITY OK US 73107
3003604053	3003604053	SMITH & NEPHEW INC.	1	N	2026-01-01	ENDOSCOPY 150 Minuteman Rd ANDOVER MA US 01810

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
149131	1255819360	K994202	ACUFEX SPIKED WASHER SYSTEM, ACUFEX SUTURE WASHER SYSTEM, ACUFEX CANCELLOUS SCREW AND SPIKED WASHER SYSTEM	HWC	2000-02-25
149135	1255819360	K994202	ACUFEX SPIKED WASHER SYSTEM, ACUFEX SUTURE WASHER SYSTEM, ACUFEX CANCELLOUS SCREW AND SPIKED WASHER SYSTEM	HWC	2000-02-25
149134	1005360707	K994143	SMITH & NEPHEW EXTERNAL FIXATION SYSTEM [UNILATERAL (LINEAR) & MULTILATERAL (CIRCULAR) FIXATORS AND ACCESSORIES]	JDW	2000-02-18
149134	2038381725	K994084	SMITH & NEPHEW XENON LIGHT SOURCES AND ACCESSORIES	FFS	2000-01-20
149135	2038381725	K994084	SMITH & NEPHEW XENON LIGHT SOURCES AND ACCESSORIES	FFS	2000-01-20
149135	1012512262	K993967	ORATEC SPINECATH INTRADISCAL CATHETER, MODEL 920002	GEI	1999-12-17
149134	1458512983	K993854	ORA-50 S AUTOTEMP ELECTROTHERMAL SPINE SYSTEM AND ACCESSORIES	GEI	1999-12-06
149134	1153261348	K993535	METAPAK MULTI-PURPOSE INSTRUMENT TRAY	FRG	2001-12-07
149135	1153261348	K993535	METAPAK MULTI-PURPOSE INSTRUMENT TRAY	FRG	2001-12-07
149131	1905238536	K992945	RCI FIXATION SCREWS (WITH ASSORTED SIZES)	HWC	1999-11-18
149135	1905238536	K992945	RCI FIXATION SCREWS (WITH ASSORTED SIZES)	HWC	1999-11-18
149131	1298661010	K992938	ROTORBLADE SUTURE ANCHOR	MAI	1999-09-23
149131	2062320165	K992396	BIORCI SCREW	HWC	2000-01-12
149135	2062320165	K992396	BIORCI SCREW	HWC	2000-01-12
149134	1857467400	K992040	FLEXISCOPE II ARTHROSCOPES AND ACCESSORIES	HRX	1999-08-06
149134	1138249055	K991323	SMITH & NEPHEW SUBCUTANEOUS ILLUMINATOR	FFS	1999-07-06
149135	1289235775	K991218	ORATEC BIPOLAR ABLATION PROBES	GEI	1999-09-13
149134	1289235775	K991218	ORATEC BIPOLAR ABLATION PROBES	GEI	1999-09-13
149135	2029230715	K991140	ORATEC INTERVENTIONS VULCAN EAS ELECTROTHERMAL ARTHROSCOPY SYSTEM AND ACCESSORIES	GEI	1999-10-25
149134	2029230715	K991140	ORATEC INTERVENTIONS VULCAN EAS ELECTROTHERMAL ARTHROSCOPY SYSTEM AND ACCESSORIES	GEI	1999-10-25
149135	1327337833	K990859	DEFLECTABLE TAC ELECTROTHERMAL PROBE	GEI	1999-06-14
149134	1327337833	K990859	DEFLECTABLE TAC ELECTROTHERMAL PROBE	GEI	1999-06-14
149134	1375770021	K990723	DYONICS VARICOSE VEIN ABLATION BLADE	GEI	1999-10-05
149135	1375770021	K990723	DYONICS VARICOSE VEIN ABLATION BLADE	GEI	1999-10-05
149131	1327625978	K990414	SMITH & NEPHEW HANDPORT SYSTEM	GCJ	1999-04-14
149131	1266598328	K984320	BIOABSORBABLE INTERFERENCE SCREWS	HWC	1999-01-28
149131	1943704214	K982963	POLYMER THREADED ANCHOR / SUTURE COMBINATION	JDI	1998-11-20
149134	1965919102	K982149	SMITH & NEPHEW DYONICS MICROLAPAROSCOPE	HET	1998-09-10
149134	1390826652	K981529	TITANIUM INTRAMEDULLARY NAIL, TITANIUM LOCKING SCREW	JDS	1998-07-09
149131	1342182902	K981156	DYONICS INTELIJET INFLOW/OUTFLOW CANNULA	HRX	1998-05-20
149135	2032968251	K980604	SMITH & NEPHEW DYONICS ENDOSCOPES AND ACCESSORIES	GCJ	1998-05-19
149131	1740962577	K980155	ENDOBUTTON CONTINUOUS LOOP	GAT	1998-04-01
149135	1740962577	K980155	ENDOBUTTON CONTINUOUS LOOP	GAT	1998-04-01
149131	1568176385	K980092	SMITH & NEPHEW DYONICS INTELIJET REUSABLE CANNULAS	FRN	1998-03-09
149131	1616162045	K972599	ACUFEX SCREW CANNULA	HWC	1997-09-19
149135	1616162045	K972599	ACUFEX SCREW CANNULA	HWC	1997-09-19
149134	1824693926	K972471	DIGITAL 3-CHIP COLOR VIDEO CAMERA, ILLUMINATORS, VIDEO COMPONENTS AND ACCESSORIES	GCJ	1997-10-24
149131	1024767135	K972326	PEBA ANCHOR/SUTURE COMBINATION	MBI	1998-02-06
149135	1024767135	K972326	PEBA ANCHOR/SUTURE COMBINATION	MBI	1998-02-06
149135	1032304183	K971253	VARIOUS ARTHROSCOPES, ENDOSCOPIC BLADES, MANUAL INSTRUMENTS	HRX	1997-06-13
149131	1708433823	K970949	SMITH & NEPHEW MIS INSTRUMENTS	GCJ	1997-04-23
149135	1971421826	K970511	DYONICS DISPOSABLE ENDOSCOPIC SURGERY BLADES	HRX	1997-08-12
149131	2021106402	K970416	ACUFEX DOUBLE ARMED SUTURE NEEDLE	GAT	1997-04-21
149134	2004788977	K970247	SMITH & NEPHEW IMAGES ARTHROSCOPE/ENT ENDOSCOPE	EOB	1997-03-21
149135	2004788977	K970247	SMITH & NEPHEW IMAGES ARTHROSCOPE/ENT ENDOSCOPE	EOB	1997-03-21
149131	1964763849	K970151	INTERCEPTRE LAPAROSCOPIC INSTRUMENTS	HET	1997-03-18
149131	1332795625	K964215	ACUFEX MOSAICPLASTY COMPREHENSIVE SYSTEM	HRX	1996-12-20
149134	1332795625	K964215	ACUFEX MOSAICPLASTY COMPREHENSIVE SYSTEM	HRX	1996-12-20
149135	1332795625	K964215	ACUFEX MOSAICPLASTY COMPREHENSIVE SYSTEM	HRX	1996-12-20
149131	1024229177	K963901	ELECTROSURGICAL PROBE	GEI	1996-11-04
149135	1024229177	K963901	ELECTROSURGICAL PROBE	GEI	1996-11-04
149134	1024229177	K963901	ELECTROSURGICAL PROBE	GEI	1996-11-04
149131	1205307985	K962789	SURGICAL KIT-ACUFEX MOSAICPLASTY SYSTEM	GEY	1996-08-14
149135	1205307985	K962789	SURGICAL KIT-ACUFEX MOSAICPLASTY SYSTEM	GEY	1996-08-14
149135	1187100914	K962075	HSW GMBH ARTHROSCOPE	HRX	1997-01-17
149131	1718482107	K961853	PROLINE FAST PASS ARTHOSCOPIC NEEDLE PASSER	HRX	1996-06-21
149131	2056229681	K961649	ACUFEX TIBIAL ANCHOR SCREW & SPIKED WASHER	HWC	1996-07-16
149131	1862985705	K961555	ACUFEX TAG BIOABSORBABLE ANCHORS	JDR	1996-07-10
149131	1843326821	K954627	ECTRA II LIGAMENT RELEASE SYSTEM	HRX	1995-12-18
149135	1843326821	K954627	ECTRA II LIGAMENT RELEASE SYSTEM	HRX	1995-12-18
149131	1669885770	K954246	ACUFEX ENDOFIX ABSORBABLE INTERFERENCE SCREW	HWC	1996-02-15
149131	1527356251	K953459	ACUFEX TAG ANCHOR	MBI	1995-08-23
149135	1527356251	K953459	ACUFEX TAG ANCHOR	MBI	1995-08-23
149134	1866463466	K953397	HEX-FIX FIELD FIXATOR	LXT	1995-10-31
149131	1758208239	K952535	ACUFEX ENDOBUTTON TAPE	GAT	1996-02-08
149135	1758208239	K952535	ACUFEX ENDOBUTTON TAPE	GAT	1996-02-08
149131	1931277773	K951859	ACUFEX ENDOBUTTON PACK	HRX	1995-06-09
149135	1931277773	K951859	ACUFEX ENDOBUTTON PACK	HRX	1995-06-09
149131	1496413016	K951451	PEBA ANCHOR (MULTIPLE SIZES)	MBI	1995-10-31
149135	1496413016	K951451	PEBA ANCHOR (MULTIPLE SIZES)	MBI	1995-10-31
149131	1466896681	K946313	TIBIAL ROUTERS, FEMORAL ROUTERS AND TUBE GRAFT SIZER	HRX	1995-03-17
149135	1466896681	K946313	TIBIAL ROUTERS, FEMORAL ROUTERS AND TUBE GRAFT SIZER	HRX	1995-03-17
149131	1102207805	K945236	AIMS CANNULATED ACL SCREW (7MM DIAMETER)	HWC	1995-02-03
149131	1096497659	K942846	ACUFEX(R) ENDO-FEMORAL AIMER	HRX	1994-09-28
149135	1096497659	K942846	ACUFEX(R) ENDO-FEMORAL AIMER	HRX	1994-09-28
149131	1508998809	K942442	ACUFEX T-FIX DELIVERY SYSTEM	MIA	1994-12-05
149135	1508998809	K942442	ACUFEX T-FIX DELIVERY SYSTEM	MIA	1994-12-05
149131	1202015188	K942079	MANUAL SURGICAL INSTRUMENTS	HRX	1994-09-28
149135	1202015188	K942079	MANUAL SURGICAL INSTRUMENTS	HRX	1994-09-28
149135	1636771034	K941967	HSW LAPAROSCOPE AND ACCESSORIES	GCJ	1994-05-16
149135	1308094858	K941364	ACUFEX T-FIX ROTATOR CUFF GUIDE SYSTEMS	HRX	1994-05-16
149131	1308094858	K941364	ACUFEX T-FIX ROTATOR CUFF GUIDE SYSTEMS	HRX	1994-05-16
149131	1901609235	K940985	ACUFEX(R) ARTHROPLASTY INSTRUMENTS	HRX	1994-05-16
149135	1901609235	K940985	ACUFEX(R) ARTHROPLASTY INSTRUMENTS	HRX	1994-05-16
149134	1901609235	K940985	ACUFEX(R) ARTHROPLASTY INSTRUMENTS	HRX	1994-05-16
149131	1330377915	K940506	ACUFEX ARTHROSCOPIC SUTURE CUTTER	HRX	1994-04-26
149131	1274614218	K940481	ACUFEX ARTHROSCOPIC SHOULDER GUIDE SYSTEM	HRX	1994-05-06
149134	1274614218	K940481	ACUFEX ARTHROSCOPIC SHOULDER GUIDE SYSTEM	HRX	1994-05-06
149135	1274614218	K940481	ACUFEX ARTHROSCOPIC SHOULDER GUIDE SYSTEM	HRX	1994-05-06
149131	2069635917	K933948	ACUFEX ENDOBUTTON SYSTEM	MAI	1994-07-21
149135	2069635917	K933948	ACUFEX ENDOBUTTON SYSTEM	MAI	1994-07-21
149134	2069635917	K933948	ACUFEX ENDOBUTTON SYSTEM	MAI	1994-07-21
149131	1784967129	K932718	ACUFEX METAL ACL CANNULA	HRX	1994-03-21
149135	1784967129	K932718	ACUFEX METAL ACL CANNULA	HRX	1994-03-21
149131	1086279116	K932460	ACUFEX MENISCAL RASPS	HRX	1994-03-22
149134	1086279116	K932460	ACUFEX MENISCAL RASPS	HRX	1994-03-22
149135	1086279116	K932460	ACUFEX MENISCAL RASPS	HRX	1994-03-22
149131	1770145599	K932027	OREGON FIXATION SYSTEM INTERFERENCE SCREW	HWC	1994-02-23
149131	1374755677	K931621	ACUFEX PRO-PAC AND ISO-PAC	HRX	1994-01-21
149135	1374755677	K931621	ACUFEX PRO-PAC AND ISO-PAC	HRX	1994-01-21
149131	1732477741	K925573	ACUFEX T-BAR	HRX	1993-05-05
149134	1732477741	K925573	ACUFEX T-BAR	HRX	1993-05-05
149135	1732477741	K925573	ACUFEX T-BAR	HRX	1993-05-05
149131	1782083976	K925437	ACUFEX CANNULATED BONE TUNNEL PLUGS	HRX	1992-12-24
149135	1782083976	K925437	ACUFEX CANNULATED BONE TUNNEL PLUGS	HRX	1992-12-24
149131	1027209974	K924514	ACUFEX FIXATION POST	HWC	1992-10-13
149135	1027209974	K924514	ACUFEX FIXATION POST	HWC	1992-10-13
149134	1099585898	K922176	INTELIJET SUCTION SUPPLY	BTA	1992-11-18
149131	1015335990	K921481	INTERFERENCE-CANNU-FLEX/SILK SCREWS-SCREW DR/G WIR	HWC	1993-08-24
149135	1015335990	K921481	INTERFERENCE-CANNU-FLEX/SILK SCREWS-SCREW DR/G WIR	HWC	1993-08-24
149134	1015335990	K921481	INTERFERENCE-CANNU-FLEX/SILK SCREWS-SCREW DR/G WIR	HWC	1993-08-24
149131	1851711573	K920621	ACUFEX PASSING PINS AND SURGICAL WIRE	HWQ	1993-05-05
149134	1851711573	K920621	ACUFEX PASSING PINS AND SURGICAL WIRE	HWQ	1993-05-05
149135	1851711573	K920621	ACUFEX PASSING PINS AND SURGICAL WIRE	HWQ	1993-05-05
149134	1905294728	K920403	XENON ARC ENDOSCOPE LIGHT SOURCE	GCJ	1992-02-21
149134	1041965955	K920024	RIHARDS TITANIUM HALF PIN	KTT	1992-01-21
149134	1071848116	K914919	SMITH & NEPHEW DYONICS LAPAROSCOPY SYSTEM	GCJ	1992-01-09

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
MBI	94	2026-07-09
HRX	70	2020-07-20
GEI	49	2023-12-11
HWC	49	2014-05-15
GAT	34	2021-02-01
GCJ	31	2022-10-20
MAI	26	2020-03-18
OLO	22	2026-03-26
KCT	16	2013-03-11
HTN	9	2019-03-12
HRS	7	2021-06-29
JDR	7	2008-11-03
SIQ	6	2026-07-06
ODA	6	2022-09-06
JWH	5	2017-11-16
OMP	5	2015-07-16
HWQ	5	1993-05-05
JDW	4	2022-12-08
KTT	4	2021-07-29
KIJ	4	1982-05-07
OWY	3	2024-11-26
HSX	3	2019-02-11
KWZ	3	2009-03-03
FLN	3	2006-02-14
LXH	3	2000-06-14
FFS	3	2000-01-20
EOB	3	1997-03-21
FWZ	3	1983-05-02
MBH	2	2026-09-08
QGY	2	2019-05-21
LYA	2	2014-06-16
LRC	2	2013-10-04
GDW	2	2013-07-12
JDI	2	2013-06-28
HIF	2	2012-08-17
KGS	2	2002-03-12
FRG	2	2001-12-07
HET	2	1998-09-10
GEY	2	1996-08-14
MIA	2	1994-12-05

PMN#

Smith & Nephew, Inc. Plates And Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP Mini-Mod, Compression Hip Screw (CHS), CONQUEST FN, And Cannulated Screws
2022-09-29
Smith & Nephew Inc.
REDAPT Sleeved Monolithic Revision Stems
2017-05-01
SMITH & NEPHEW INC.

SMITH & NEPHEW INC.

FDA Registration(s)#

Registered Device Listings#

Product Codes Associated With Registrations#

PMN#

Smith & Nephew, Inc. Plates And Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP Mini-Mod, Compression Hip Screw (CHS), CONQUEST FN, And Cannulated Screws

REDAPT Sleeved Monolithic Revision Stems