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, lumbar (MAX) (6) APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY (KWQ) (4)

Premarket Exempt

Clear

Arena-L® - 00190361039310 Catalog Number :

Device Description : 21X27 TRIAL HEAD, ARENA-L ALLO, 12MM

Device Class : 2

Duns Number: 002003243

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

Arena-L® - 00190361039327 Catalog Number :

Device Description : 21X27 TRIAL HEAD, ARENA-L ALLO, 14MM

Device Class : 2

Duns Number: 002003243

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

Arena-L® - 00190361039334 Catalog Number :

Device Description : 21X27 TRIAL HEAD, ARENA-L ALLO, 16MM

Device Class : 2

Duns Number: 002003243

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

Arena-L® - 00190361039341 Catalog Number :

Device Description : 21X27 TRIAL HEAD, ARENA-L ALLO, 18MM

Device Class : 2

Duns Number: 002003243

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

Arena-L® - 00190361039358 Catalog Number :

Device Description : 21X27 TRIAL HEAD, ARENA-L ALLO, 20MM

Device Class : 2

Duns Number: 002003243

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

E-LIFT® - 00190361039365 Catalog Number :

Device Description : ELIFT Inserter

Device Class : 2

Duns Number: 002003243

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

Indus® - 00190361039372 Catalog Number :

Device Description : Invue Trial Drill Guide, 5mm

Device Class : 2

Duns Number: 002003243

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

Indus® - 00190361039389 Catalog Number :

Device Description : Invue Trial Drill Guide, 6mm

Device Class : 2

Duns Number: 002003243

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

Indus® - 00190361039396 Catalog Number :

Device Description : Invue Trial Drill Guide, 7mm

Device Class : 2

Duns Number: 002003243

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

Indus® - 00190361039402 Catalog Number :

Device Description : Invue Trial Drill Guide, 8mm

Device Class : 2

Duns Number: 002003243

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

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