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

Premarket Exempt

Clear

Isobar - 03661380008801 Catalog Number :

Device Description : Monoaxial hemispherical screw Ø 5.5 Lg 40 mm

Device Class : 2

Duns Number: 502816283

Premarket Exempt : No

Product Code : KWQ, MNH, KWP, MNI

Prescription Use : Yes

Device Count : 1

Isobar - 03661380008818 Catalog Number :

Device Description : Monoaxial hemispherical screw Ø 5.5 Lg 45 mm

Device Class : 2

Duns Number: 502816283

Premarket Exempt : No

Product Code : KWQ, MNH, KWP, MNI

Prescription Use : Yes

Device Count : 1

Isobar - 03661380008825 Catalog Number :

Device Description : Monoaxial hemispherical screw Ø 5.5 Lg 50 mm

Device Class : 2

Duns Number: 502816283

Premarket Exempt : No

Product Code : KWP, MNH, MNI, KWQ

Prescription Use : Yes

Device Count : 1

Isobar - 03661380008832 Catalog Number :

Device Description : Monoaxial hemispherical screw Ø 6.2 Lg 35 mm

Device Class : 2

Duns Number: 502816283

Premarket Exempt : No

Product Code : KWP, MNI, KWQ, MNH

Prescription Use : Yes

Device Count : 1

Isobar - 03661380008849 Catalog Number :

Device Description : Monoaxial hemispherical screw Ø 6.2 Lg 40 mm

Device Class : 2

Duns Number: 502816283

Premarket Exempt : No

Product Code : MNI, KWQ, KWP, MNH

Prescription Use : Yes

Device Count : 1

Isobar - 03661380008863 Catalog Number :

Device Description : Monoaxial hemispherical screw Ø 6.2 Lg 45 mm

Device Class : 2

Duns Number: 502816283

Premarket Exempt : No

Product Code : KWP, MNI, KWQ, MNH

Prescription Use : Yes

Device Count : 1

Isobar - 03661380008887 Catalog Number :

Device Description : Monoaxial hemispherical screw Ø 6.2 Lg 50 mm

Device Class : 2

Duns Number: 502816283

Premarket Exempt : No

Product Code : MNI, KWQ, MNH, KWP

Prescription Use : Yes

Device Count : 1

Isobar - 03661380008900 Catalog Number :

Device Description : Monoaxial hemispherical screw Ø 6.2 Lg 55 mm

Device Class : 2

Duns Number: 502816283

Premarket Exempt : No

Product Code : KWQ, KWP, MNI, MNH

Prescription Use : Yes

Device Count : 1

Isobar - 03661380008962 Catalog Number :

Device Description : Monoaxial hemispherical screw Ø 7.0 Lg 30 mm

Device Class : 2

Duns Number: 502816283

Premarket Exempt : No

Product Code : KWP, KWQ, MNH, MNI

Prescription Use : Yes

Device Count : 1

Isobar - 03661380008979 Catalog Number :

Device Description : Monoaxial hemispherical screw Ø 7.0 Lg 35 mm

Device Class : 2

Duns Number: 502816283

Premarket Exempt : No

Product Code : KWP, MNI, MNH, KWQ

Prescription Use : Yes

Device Count : 1

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