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) (6) Orthopedic Manual Surgical Instrument (LXH) (2) Screw, Fixation, Bone (HWC) (2)

Premarket Exempt

No Yes

Clear

General Instrument - 00817701028062 Catalog Number :

Device Description : Nextremity 2.0mm x 4" K-Wire Sterile

Device Class : 1

Duns Number: 060783407

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

General Instrument - 00817701028079 Catalog Number :

Device Description : Lapidus Cut Guide

Device Class : 1

Duns Number: 060783407

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

InCore Lapidus - 00817701028086 Catalog Number :

Device Description : InCore Lapdius 5.9mm x 28mm Right Titanium Post

Device Class : 2

Duns Number: 060783407

Premarket Exempt : No

Product Code : HWC

Prescription Use : No

Device Count : 1

InCore Lapidus - 00817701028093 Catalog Number :

Device Description : InCore Lapdius 5.9mm x 28mm Left Titanium Post

Device Class : 2

Duns Number: 060783407

Premarket Exempt : No

Product Code : HWC

Prescription Use : No

Device Count : 1

Axi+Line Bunion Correction System - 00817701028109 Catalog Number :

Device Description : Axi+Line Plate 5.0 Degree Left

Device Class : 2

Duns Number: 060783407

Premarket Exempt : No

Product Code : HRS

Prescription Use : No

Device Count : 1

Axi+Line Bunion Correction System - 00817701028116 Catalog Number :

Device Description : Axi+Line Plate 5.0 Degree Right

Device Class : 2

Duns Number: 060783407

Premarket Exempt : No

Product Code : HRS

Prescription Use : No

Device Count : 1

Axi+Line Bunion Correction System - 00817701028123 Catalog Number :

Device Description : Axi+Line Plate 7.5 Degree Left

Device Class : 2

Duns Number: 060783407

Premarket Exempt : No

Product Code : HRS

Prescription Use : No

Device Count : 1

Axi+Line Bunion Correction System - 00817701028130 Catalog Number :

Device Description : Axi+Line Plate 7.5 Degree Right

Device Class : 2

Duns Number: 060783407

Premarket Exempt : No

Product Code : HRS

Prescription Use : No

Device Count : 1

Axi+Line Bunion Correction System - 00817701028147 Catalog Number :

Device Description : Axi-Line Plate 10.0 Degree Left

Device Class : 2

Duns Number: 060783407

Premarket Exempt : No

Product Code : HRS

Prescription Use : No

Device Count : 1

Axi+Line Bunion Correction System - 00817701028154 Catalog Number :

Device Description : Axi+Line Plate 10.0 Degree Right

Device Class : 2

Duns Number: 060783407

Premarket Exempt : No

Product Code : HRS

Prescription Use : No

Device Count : 1

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