SCIENT'X

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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

APPLIANCE, FIXATION, SPINAL INTERLAMINAL (KWP) (10) ORTHOSIS, SPINAL PEDICLE FIXATION (MNI) (10) Orthosis, spondylolisthesis spinal fixation (MNH) (10) APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY (KWQ) (4)

Premarket Exempt

Clear

Isobar - 03661380009129 Catalog Number :

Device Description : Polyaxial hemispherical screw Ø 4.5 Lg 35 mm

Device Class : 2

Duns Number: 502816283

Premarket Exempt : No

Product Code : KWP, KWQ, MNH, MNI

Prescription Use : Yes

Device Count : 1

Isobar - 03661380009136 Catalog Number :

Device Description : Polyaxial hemispherical screw Ø 4.5 Lg 40 mm

Device Class : 2

Duns Number: 502816283

Premarket Exempt : No

Product Code : KWP, KWQ, MNI, MNH

Prescription Use : Yes

Device Count : 1

Isobar - 03661380009143 Catalog Number :

Device Description : Polyaxial hemispherical screw Ø 4.5 Lg 45 mm

Device Class : 2

Duns Number: 502816283

Premarket Exempt : No

Product Code : KWQ, MNH, MNI, KWP

Prescription Use : Yes

Device Count : 1

Isobar - 03661380009150 Catalog Number :

Device Description : Polyaxial hemispherical screw Ø 4.5 Lg 50 mm

Device Class : 2

Duns Number: 502816283

Premarket Exempt : No

Product Code : MNH, KWQ, MNI, KWP

Prescription Use : Yes

Device Count : 1

Isobar - 03661380009174 Catalog Number :

Device Description : Polyaxial hemispherical screw Ø 5.5 Lg 35 mm

Device Class : 2

Duns Number: 502816283

Premarket Exempt : No

Product Code : KWP, MNI, MNH

Prescription Use : Yes

Device Count : 1

Isobar - 03661380009181 Catalog Number :

Device Description : Polyaxial hemispherical screw Ø 5.5 Lg 40 mm

Device Class : 2

Duns Number: 502816283

Premarket Exempt : No

Product Code : MNI, MNH, KWP

Prescription Use : Yes

Device Count : 1

Isobar - 03661380009198 Catalog Number :

Device Description : Polyaxial hemispherical screw Ø 5.5 Lg 45 mm

Device Class : 2

Duns Number: 502816283

Premarket Exempt : No

Product Code : MNH, MNI, KWP

Prescription Use : Yes

Device Count : 1

Isobar - 03661380009235 Catalog Number :

Device Description : Polyaxial hemispherical screw Ø 6.2 Lg 40 mm

Device Class : 2

Duns Number: 502816283

Premarket Exempt : No

Product Code : MNH, MNI, KWP

Prescription Use : Yes

Device Count : 1

Isobar - 03661380009259 Catalog Number :

Device Description : Polyaxial hemispherical screw Ø 6.2 Lg 45 mm

Device Class : 2

Duns Number: 502816283

Premarket Exempt : No

Product Code : MNH, MNI, KWP

Prescription Use : Yes

Device Count : 1

Isobar - 03661380009273 Catalog Number :

Device Description : Polyaxial hemispherical screw Ø 6.2 Lg 50 mm

Device Class : 2

Duns Number: 502816283

Premarket Exempt : No

Product Code : MNH, MNI, KWP

Prescription Use : Yes

Device Count : 1

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