SPINEFRONTIER, INC.

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

Intervertebral fusion device with bone graft, cervical (ODP) (5) APPLIANCE, FIXATION, SPINAL INTERLAMINAL (KWP) (4) Intervertebral fusion device with bone graft, lumbar (MAX) (1)

Premarket Exempt

No

Clear

InSpan® - 00190361000006 Catalog Number :

Device Description : InSpan, SP Plate 8mm x 35mm

Device Class : 2

Duns Number: 002003243

Premarket Exempt : No

Product Code : KWP

Prescription Use : Yes

Device Count : 1

InSpan® - 00190361000013 Catalog Number :

Device Description : InSpan, SP Plate 8mm x 37mm

Device Class : 2

Duns Number: 002003243

Premarket Exempt : No

Product Code : KWP

Prescription Use : Yes

Device Count : 1

InSpan® - 00190361000020 Catalog Number :

Device Description : InSpan, SP Plate 8mm x 39mm

Device Class : 2

Duns Number: 002003243

Premarket Exempt : No

Product Code : KWP

Prescription Use : Yes

Device Count : 1

InSpan® - 00190361000037 Catalog Number :

Device Description : InSpan, SP Plate 8mm x 41mm

Device Class : 2

Duns Number: 002003243

Premarket Exempt : No

Product Code : KWP

Prescription Use : Yes

Device Count : 1

Arena-C® - 00190361000044 Catalog Number :

Device Description : Arena C, Straight, 12x15x5mm

Device Class : 2

Duns Number: 002003243

Premarket Exempt : No

Product Code : ODP

Prescription Use : Yes

Device Count : 1

Arena-C® - 00190361000051 Catalog Number :

Device Description : Arena-C, Straight, 12x15x6mm

Device Class : 2

Duns Number: 002003243

Premarket Exempt : No

Product Code : ODP

Prescription Use : Yes

Device Count : 1

Arena-C® - 00190361000068 Catalog Number :

Device Description : Arena-C, Straight, 12x15x7mm

Device Class : 2

Duns Number: 002003243

Premarket Exempt : No

Product Code : ODP

Prescription Use : Yes

Device Count : 1

Arena-C® - 00190361000075 Catalog Number :

Device Description : Arena-C, Straight, 12x15x8mm

Device Class : 2

Duns Number: 002003243

Premarket Exempt : No

Product Code : ODP

Prescription Use : Yes

Device Count : 1

Arena-C® - 00190361000082 Catalog Number :

Device Description : Arena-C, Straight, 12x15x9mm

Device Class : 2

Duns Number: 002003243

Premarket Exempt : No

Product Code : ODP

Prescription Use : Yes

Device Count : 1

Arena-L® - 00190361000099 Catalog Number :

Device Description : Arena-L, Lordotic 10 degrees, 35X26X08

Device Class : 2

Duns Number: 002003243

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

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