Nextremity Solutions, Inc.

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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

Plate, Fixation, Bone (HRS) (4) Screw, Fixation, Bone (HWC) (4) Orthopedic Manual Surgical Instrument (LXH) (2) Blade, Saw, General & Plastic Surgery, Surgical (GFA) (1)

Premarket Exempt

No Yes

Clear

Nextra PEEK Hammertoe Correction System - 00817701028444 Catalog Number :

Device Description : PEEK Hammertoe Angled Middle 4.25mm

Device Class : 2

Duns Number: 060783407

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

Nextra PEEK Hammertoe Correction System - 00817701028451 Catalog Number :

Device Description : PEEK Hammertoe Angled Middle 5.0mm

Device Class : 2

Duns Number: 060783407

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

Nextra PEEK Hammertoe Correction System - 00817701028468 Catalog Number :

Device Description : PEEK Hammertoe Proximal 3.2mm Instrument Kit w/ Implant

Device Class : 2

Duns Number: 060783407

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

Nextra PEEK Hammertoe Correction System - 00817701028475 Catalog Number :

Device Description : PEEK Hammertoe Proximal 4.2mm Instrument Kit w/ Implant

Device Class : 2

Duns Number: 060783407

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

Nextremity General Instrument - 00817701028482 Catalog Number :

Device Description : Lapidus Cut Guide Disposable Set

Device Class : 1

Duns Number: 060783407

Premarket Exempt : Yes

Product Code : LXH, GFA

Prescription Use : Yes

Device Count : 1

Stratum Foot Plating System - 00817701028499 Catalog Number :

Device Description : STRATUM 1st Metatarsophalangeal Joint (MPJ) Revision Plate Small - Left

Device Class : 2

Duns Number: 060783407

Premarket Exempt : No

Product Code : HRS

Prescription Use : Yes

Device Count : 1

Stratum Foot Plating System - 00817701028505 Catalog Number :

Device Description : STRATUM 1st Metatarsophalangeal Joint (MPJ) Revision Plate Small - Right

Device Class : 2

Duns Number: 060783407

Premarket Exempt : No

Product Code : HRS

Prescription Use : Yes

Device Count : 1

Stratum Foot Plating System - 00817701028512 Catalog Number :

Device Description : STRATUM 1st Metatarsophalangeal Joint (MPJ) Revision Plate Large - Left

Device Class : 2

Duns Number: 060783407

Premarket Exempt : No

Product Code : HRS

Prescription Use : Yes

Device Count : 1

Stratum Foot Plating System - 00817701028529 Catalog Number :

Device Description : STRATUM 1st Metatarsophalangeal Joint (MPJ) Revision Plate Large - Right

Device Class : 2

Duns Number: 060783407

Premarket Exempt : No

Product Code : HRS

Prescription Use : Yes

Device Count : 1

Stratum Foot Plating System - 00817701028536 Catalog Number :

Device Description : STRATUM 1st Metatarsophalangeal Joint (MPJ) Revision Trials

Device Class : 1

Duns Number: 060783407

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

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