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) (5) APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY (KWQ) (2) Sacroiliac joint fixation (OUR) (1)

Premarket Exempt

Clear

Indus® - 00190361039518 Catalog Number :

Device Description : 11mm Trial Drill Guide, Lordotic

Device Class : 2

Duns Number: 002003243

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

Indus® - 00190361039525 Catalog Number :

Device Description : 12mm Trial Drill Guide, Lordotic

Device Class : 2

Duns Number: 002003243

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

InSpan® - 00190361039532 Catalog Number :

Device Description : 8mm InSpan Sizing Trial

Device Class : 2

Duns Number: 002003243

Premarket Exempt : No

Product Code : KWP

Prescription Use : Yes

Device Count : 1

InSpan® - 00190361039549 Catalog Number :

Device Description : 10mm InSpan Sizing Trial

Device Class : 2

Duns Number: 002003243

Premarket Exempt : No

Product Code : KWP

Prescription Use : Yes

Device Count : 1

InSpan® - 00190361039556 Catalog Number :

Device Description : 12mm InSpan Sizing Trial

Device Class : 2

Duns Number: 002003243

Premarket Exempt : No

Product Code : KWP

Prescription Use : Yes

Device Count : 1

InSpan® - 00190361039563 Catalog Number :

Device Description : 14mm InSpan Sizing Trial

Device Class : 2

Duns Number: 002003243

Premarket Exempt : No

Product Code : KWP

Prescription Use : Yes

Device Count : 1

InSpan® - 00190361039570 Catalog Number :

Device Description : 16mm InSpan Sizing Trial

Device Class : 2

Duns Number: 002003243

Premarket Exempt : No

Product Code : KWP

Prescription Use : Yes

Device Count : 1

SacroFuse® - 00190361039587 Catalog Number :

Device Description : INSERTER, SACROFUSE

Device Class : 2

Duns Number: 002003243

Premarket Exempt : No

Product Code : OUR

Prescription Use : Yes

Device Count : 1

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