INDIUS MEDICAL TECHNOLOGIES PRIVATE LIMITED

Address:Unit No.12,Pune Maharashtra,IN

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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

Appliance, Fixation, Spinal Intervertebral Body (KWQ) (10) Appliance, Fixation, Spinal Interlaminal (KWP) (8) Thoracolumbosacral Pedicle Screw System (NKB) (8)

Premarket Exempt

No Yes

Clear

SEA-LINK Anterior Cervical Ø 4.5 mm L 18 mm Variable Angle Self Drilling Screw - B922A00345180 Catalog Number : A003.4518

Device Description : SEA-LINK Anterior Cervical Plate System Ø 4.5 mm L 18 mm Variable Angle Self Dri SEA-LINK Anterior Cervical Plate System Ø 4.5 mm L 18 mm Variable Angle Self Drilling Screw

Device Class : 2

Duns Number: 860396609

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

SEA-LINK Anterior Cervical Ø 4.5 mm L 20 mm Variable Angle Self Drilling Screw - B922A00345200 Catalog Number : A003.4520

Device Description : SEA-LINK Anterior Cervical Plate System Ø 4.5 mm L 20 mm Variable Angle Self Dri SEA-LINK Anterior Cervical Plate System Ø 4.5 mm L 20 mm Variable Angle Self Drilling Screw

Device Class : 2

Duns Number: 860396609

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

ACURA Stabilization System - B922A00401250 Catalog Number : A004.0125

Device Description : ACURA Stabilization System 4.5 mm x 25 mm Polyaxial Screw

Device Class : 2

Duns Number: 860396609

Premarket Exempt : No

Product Code : KWP, NKB, KWQ

Prescription Use : Yes

Device Count : 1

ACURA Stabilization System - B922A00401300 Catalog Number : A004.0130

Device Description : ACURA Stabilization System 4.5 mm x 30 mm Polyaxial Screw

Device Class : 2

Duns Number: 860396609

Premarket Exempt : No

Product Code : KWP, NKB, KWQ

Prescription Use : Yes

Device Count : 1

ACURA Stabilization System - B922A00401350 Catalog Number : A004.0135

Device Description : ACURA Stabilization System 4.5 mm x 35 mm Polyaxial Screw

Device Class : 2

Duns Number: 860396609

Premarket Exempt : No

Product Code : KWP, NKB, KWQ

Prescription Use : Yes

Device Count : 1

ACURA Stabilization System - B922A00401400 Catalog Number : A004.0140

Device Description : ACURA Stabilization System 4.5 mm x 40 mm Polyaxial Screw

Device Class : 2

Duns Number: 860396609

Premarket Exempt : No

Product Code : KWP, NKB, KWQ

Prescription Use : Yes

Device Count : 1

ACURA Stabilization System 4.5 mm x 45 mm Polyaxial Screw - B922A00401450 Catalog Number : A004.0145

Device Description : ACURA Stabilization System 4.5 mm x 45 mm Polyaxial Screw

Device Class : 2

Duns Number: 860396609

Premarket Exempt : No

Product Code : KWP, NKB, KWQ

Prescription Use : Yes

Device Count : 1

ACURA Stabilization System - B922A00402300 Catalog Number : A004.0230

Device Description : ACURA Stabilization System 5.5 mm x 30 mm Polyaxial Screw

Device Class : 2

Duns Number: 860396609

Premarket Exempt : No

Product Code : KWP, NKB, KWQ

Prescription Use : Yes

Device Count : 1

ACURA Stabilization System - B922A00402350 Catalog Number : A004.0235

Device Description : ACURA Stabilization System 5.5 mm x 35 mm Polyaxial Screw

Device Class : 2

Duns Number: 860396609

Premarket Exempt : No

Product Code : KWP, NKB, KWQ

Prescription Use : Yes

Device Count : 1

ACURA Stabilization System - B922A00402400 Catalog Number : A004.0240

Device Description : ACURA Stabilization System 5.5 mm x 40 mm Polyaxial Screw

Device Class : 2

Duns Number: 860396609

Premarket Exempt : No

Product Code : KWP, NKB, KWQ

Prescription Use : Yes

Device Count : 1

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