SPINEFRONTIER, INC.

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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)

Premarket Exempt

Clear

InSpan® - 00190361000419 Catalog Number :

Device Description : InSpan Slim, SP Plate, 8x35mm

Device Class : 2

Duns Number: 002003243

Premarket Exempt : No

Product Code : KWP

Prescription Use : Yes

Device Count : 1

InSpan® - 00190361000426 Catalog Number :

Device Description : InSpan Slim, SP Plate, 8x43mm

Device Class : 2

Duns Number: 002003243

Premarket Exempt : No

Product Code : KWP

Prescription Use : Yes

Device Count : 1

InSpan® - 00190361000433 Catalog Number :

Device Description : InSpan Slim, SP Plate, 10x37mm

Device Class : 2

Duns Number: 002003243

Premarket Exempt : No

Product Code : KWP

Prescription Use : Yes

Device Count : 1

InSpan® - 00190361000440 Catalog Number :

Device Description : InSpan Slim, SP Plate, 12x39mm

Device Class : 2

Duns Number: 002003243

Premarket Exempt : No

Product Code : KWP

Prescription Use : Yes

Device Count : 1

InSpan® - 00190361000457 Catalog Number :

Device Description : InSpan Slim, SP Plate, 14x41mm

Device Class : 2

Duns Number: 002003243

Premarket Exempt : No

Product Code : KWP

Prescription Use : Yes

Device Count : 1

InSpan® - 00190361000464 Catalog Number :

Device Description : InSpan Slim, SP Plate, 16x43mm

Device Class : 2

Duns Number: 002003243

Premarket Exempt : No

Product Code : KWP

Prescription Use : Yes

Device Count : 1

InSpan® - 00190361000471 Catalog Number :

Device Description : ISP Plate, 8x45mm

Device Class : 2

Duns Number: 002003243

Premarket Exempt : No

Product Code : KWP

Prescription Use : Yes

Device Count : 1

InSpan® - 00190361000488 Catalog Number :

Device Description : ISP Plate, 10x45mm

Device Class : 2

Duns Number: 002003243

Premarket Exempt : No

Product Code : KWP

Prescription Use : Yes

Device Count : 1

InSpan® - 00190361000495 Catalog Number :

Device Description : ISP Plate, 12x45mm

Device Class : 2

Duns Number: 002003243

Premarket Exempt : No

Product Code : KWP

Prescription Use : Yes

Device Count : 1

InSpan® - 00190361000501 Catalog Number :

Device Description : ISP Plate, 14x45mm

Device Class : 2

Duns Number: 002003243

Premarket Exempt : No

Product Code : KWP

Prescription Use : Yes

Device Count : 1

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