SCIENT'X

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

No

Clear

Isobar - 03661380003417 Catalog Number :

Device Description : Transverse connecting bar Lg 100 mm

Device Class : 2

Duns Number: 502816283

Premarket Exempt : No

Product Code : MNH, MNI, KWQ, KWP

Prescription Use : Yes

Device Count : 1

Isobar - 03661380003424 Catalog Number :

Device Description : Transverse connecting bar Lg 40 mm

Device Class : 2

Duns Number: 502816283

Premarket Exempt : No

Product Code : KWP, MNH, MNI, KWQ

Prescription Use : Yes

Device Count : 1

Isobar - 03661380003431 Catalog Number :

Device Description : Transverse connecting bar Lg 50 mm

Device Class : 2

Duns Number: 502816283

Premarket Exempt : No

Product Code : KWQ, KWP, MNI, MNH

Prescription Use : Yes

Device Count : 1

Isobar - 03661380003448 Catalog Number :

Device Description : Transverse connecting bar Lg 60 mm

Device Class : 2

Duns Number: 502816283

Premarket Exempt : No

Product Code : MNH, MNI, KWP, KWQ

Prescription Use : Yes

Device Count : 1

Isobar - 03661380003455 Catalog Number :

Device Description : Transverse connecting bar Lg 80 mm

Device Class : 2

Duns Number: 502816283

Premarket Exempt : No

Product Code : KWP, KWQ, MNI, MNH

Prescription Use : Yes

Device Count : 1

Isobar - 03661380008757 Catalog Number :

Device Description : Monoaxial hemispherical screw Ø 4.5 Lg 25 mm

Device Class : 2

Duns Number: 502816283

Premarket Exempt : No

Product Code : KWP, MNI, KWQ, MNH

Prescription Use : Yes

Device Count : 1

Isobar - 03661380008764 Catalog Number :

Device Description : Monoaxial hemispherical screw Ø 4.5 Lg 30 mm

Device Class : 2

Duns Number: 502816283

Premarket Exempt : No

Product Code : MNI, KWP, MNH, KWQ

Prescription Use : Yes

Device Count : 1

Isobar - 03661380008771 Catalog Number :

Device Description : Monoaxial 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 - 03661380008788 Catalog Number :

Device Description : Monoaxial hemispherical screw Ø 5.5 Lg 30 mm

Device Class : 2

Duns Number: 502816283

Premarket Exempt : No

Product Code : MNI, KWQ, MNH, KWP

Prescription Use : Yes

Device Count : 1

Isobar - 03661380008795 Catalog Number :

Device Description : Monoaxial hemispherical screw Ø 5.5 Lg 35 mm

Device Class : 2

Duns Number: 502816283

Premarket Exempt : No

Product Code : KWP, MNI, KWQ, MNH

Prescription Use : Yes

Device Count : 1

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