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

Orthopedic Manual Surgical Instrument (LXH) (5) Screw, Fixation, Bone (HWC) (4) Plate, Fixation, Bone (HRS) (1)

Premarket Exempt

No Yes

Clear

Stratum RS - 00817701027935 Catalog Number :

Device Description : Stratum RS Multi Directional Screw 2.4 x 44mm - Sterile

Device Class : 2

Duns Number: 060783407

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

Stratum RS - 00817701027942 Catalog Number :

Device Description : Stratum RS Multi Directional Screw 2.4 x 46mm - Sterile

Device Class : 2

Duns Number: 060783407

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

Stratum RS - 00817701027959 Catalog Number :

Device Description : Stratum RS Multi Directional Screw 2.4 x 48mm - Sterile

Device Class : 2

Duns Number: 060783407

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

Stratum RS - 00817701027966 Catalog Number :

Device Description : Stratum RS Multi Directional Screw 24 x 50mm - Sterile

Device Class : 2

Duns Number: 060783407

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

Stratum RS - 00817701027980 Catalog Number :

Device Description : STRM TORQ LIM DRIVER T10 RS ST

Device Class : 1

Duns Number: 060783407

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

Stratum RS - 00817701028000 Catalog Number :

Device Description : STRM Threaded Wire and Nut RS ST

Device Class : 1

Duns Number: 060783407

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

Stratum RS - 00817701028017 Catalog Number :

Device Description : Stratum Reduced Size Standard Instrument Kit

Device Class : 2

Duns Number: 060783407

Premarket Exempt : No

Product Code : HRS

Prescription Use : Yes

Device Count : 1

Stratum RS - 00817701028024 Catalog Number :

Device Description : Stratum Screw Driver Hex 2mm ST

Device Class : 1

Duns Number: 060783407

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

Stratum RS - 00817701028031 Catalog Number :

Device Description : Stratum Reduced Size Calibrated Drill 2.0mm Sterile with Sleeve

Device Class : 1

Duns Number: 060783407

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

Stratum Foot Plating System - 00817701028055 Catalog Number :

Device Description : Stratum Non-Sterile Threaded Wire

Device Class : 1

Duns Number: 060783407

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

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