Smith & Nephew, Inc.

Address:7135 Goodlett Farms Pkwy,Cordova,TN,38016,US

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE (MBI) (5) SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE (GAT) (2) Screw, fixation, bone (HWC) (2) BIT, DRILL (HTW) (1)

Premarket Exempt

No Yes

Clear

SPEEDLOCK - 00817470001099 Catalog Number : OM-9758

Device Description : SPEEDLOCK PLUS KIT W/ MAGNUMWIRE (BLACK)

Device Class : 2

Duns Number: 109903521

Premarket Exempt : No

Product Code : MBI

Prescription Use : Yes

Device Count : 1

SMARTSTITCH PERFECTPASSER - 00817470001105 Catalog Number : OM-8177EA

Device Description : SMARSTITCH PP MW BLACK COBRAID

Device Class : 2

Duns Number: 109903521

Premarket Exempt : No

Product Code : GAT

Prescription Use : Yes

Device Count : 1

SMARTSTITCH PERFECTPASSER - 00817470001112 Catalog Number : OM-8177

Device Description : SMARTSTITCH PERFECTPASSER MAGNUMWIRE SUTURE C SMARTSTITCH PERFECTPASSER MAGNUMWIRE SUTURE CARTRIDGES, BLACK CO-BRAID

Device Class : 2

Duns Number: 109903521

Premarket Exempt : No

Product Code : GAT

Prescription Use : Yes

Device Count : 1

MAGNUM - 00817470001129 Catalog Number : OM-9128

Device Description : MAGNUM PLUS 2.8 MM KNOTLESS IMPLANT SET WITH MAGNUM PLUS 2.8 MM KNOTLESS IMPLANT SET WITH PERFECTPASSER MAGNUMWIRE SUTURE CARTRIDGE, BLACK CO-BRAID

Device Class : 2

Duns Number: 109903521

Premarket Exempt : No

Product Code : MBI

Prescription Use : Yes

Device Count : 1

N/A - 00817470001150 Catalog Number : 21-1019

Device Description : DRILL-TIP GUIDEWIRE 254MM(10IN)LX2.4MMD

Device Class : 1

Duns Number: 109903521

Premarket Exempt : Yes

Product Code : HTW

Prescription Use : Yes

Device Count : 1

MAGNUM - 00817470001211 Catalog Number : OM-9138

Device Description : MAGNUM X PLUS PP MW BLACK COBRAID

Device Class : 2

Duns Number: 109903521

Premarket Exempt : No

Product Code : MBI

Prescription Use : Yes

Device Count : 1

SPEEDSCREW - 00817470001242 Catalog Number : OM-9168

Device Description : SPEEDSCREW 5.5MM PLUS W/PP MW BLACK COB

Device Class : 2

Duns Number: 109903521

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

SPEEDSCREW - 00817470001259 Catalog Number : OM-9188

Device Description : SPEEDSCREW 6.5MM PLUS PP MW BLACK COB

Device Class : 2

Duns Number: 109903521

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

N/A - 00817470001273 Catalog Number : 22-8065

Device Description : PEEK SUTURE ANCHOR 6.5MM NON-NEEDLED

Device Class : 2

Duns Number: 109903521

Premarket Exempt : No

Product Code : MBI

Prescription Use : Yes

Device Count : 1

N/A - 00817470001297 Catalog Number : 22-8065N

Device Description : PEEK SUTURE ANCHOR 6.5MM NEEDLED

Device Class : 2

Duns Number: 109903521

Premarket Exempt : No

Product Code : MBI

Prescription Use : Yes

Device Count : 1

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