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)

Premarket Exempt

No Yes

Clear

SEA-LINK Anterior Cervical Ø 4.0 mm L 10 mm Variable Angle Self Drilling Screw - B922A00344100 Catalog Number : A003.4410

Device Description : SEA-LINK Anterior Cervical Plate System Ø 4.0 mm L 10 mm Variable Angle Self Dri SEA-LINK Anterior Cervical Plate System Ø 4.0 mm L 10 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 4.0 mm L 12 mm Variable Angle Self Drilling Screw - B922A00344120 Catalog Number : A003.4412

Device Description : SEA-LINK Anterior Cervical Plate System Ø 4.0 mm L 12 mm Variable Angle Self Dri SEA-LINK Anterior Cervical Plate System Ø 4.0 mm L 12 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 4.0 mm L 14 mm Variable Angle Self Drilling Screw - B922A00344140 Catalog Number : A003.4414

Device Description : SEA-LINK Anterior Cervical Plate System Ø 4.0 mm L 14 mm Variable Angle Self Dri SEA-LINK Anterior Cervical Plate System Ø 4.0 mm L 14 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 4.0 mm L 16 mm Variable Angle Self Drilling Screw - B922A00344160 Catalog Number : A003.4416

Device Description : SEA-LINK Anterior Cervical Plate System Ø 4.0 mm L 16 mm Variable Angle Self Dri SEA-LINK Anterior Cervical Plate System Ø 4.0 mm L 16 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 4.0 mm L 18 mm Variable Angle Self Drilling Screw - B922A00344180 Catalog Number : A003.4418

Device Description : SEA-LINK Anterior Cervical Plate System Ø 4.0 mm L 18 mm Variable Angle Self Dri SEA-LINK Anterior Cervical Plate System Ø 4.0 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 4.0 mm L 20 mm Variable Angle Self Drilling Screw - B922A00344200 Catalog Number : A003.4420

Device Description : SEA-LINK Anterior Cervical Plate System Ø 4.0 mm L 20 mm Variable Angle Self Dri SEA-LINK Anterior Cervical Plate System Ø 4.0 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

SEA-LINK Anterior Cervical Ø 4.5 mm L 10 mm Variable Angle Self Drilling Screw - B922A00345100 Catalog Number : A003.4510

Device Description : SEA-LINK Anterior Cervical Plate System Ø 4.5 mm L 10 mm Variable Angle Self Dri SEA-LINK Anterior Cervical Plate System Ø 4.5 mm L 10 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 12 mm Variable Angle Self Drilling Screw - B922A00345120 Catalog Number : A003.4512

Device Description : SEA-LINK Anterior Cervical Plate System Ø 4.5 mm L 12 mm Variable Angle Self Dri SEA-LINK Anterior Cervical Plate System Ø 4.5 mm L 12 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 14 mm Variable Angle Self Drilling Screw - B922A00345140 Catalog Number : A003.4514

Device Description : SEA-LINK Anterior Cervical Plate System Ø 4.5 mm L 14 mm Variable Angle Self Dri SEA-LINK Anterior Cervical Plate System Ø 4.5 mm L 14 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 16 mm Variable Angle Self Drilling Screw - B922A00345160 Catalog Number : A003.4516

Device Description : SEA-LINK Anterior Cervical Plate System Ø 4.5 mm L 16 mm Variable Angle Self Dri SEA-LINK Anterior Cervical Plate System Ø 4.5 mm L 16 mm Variable Angle Self Drilling Screw

Device Class : 2

Duns Number: 860396609

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

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