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) (10)

Premarket Exempt

Clear

Arena-L® - 00190361039211 Catalog Number :

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

Device Class : 2

Duns Number: 002003243

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

Arena-L® - 00190361039228 Catalog Number :

Device Description : 21X27 TRIAL RASP HEAD, ARENA-L ALLO, 8MM

Device Class : 2

Duns Number: 002003243

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

Arena-L® - 00190361039235 Catalog Number :

Device Description : 21X27 TRIAL RASP HEAD, ARENA-L ALLO, 10MM

Device Class : 2

Duns Number: 002003243

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

Arena-L® - 00190361039242 Catalog Number :

Device Description : 21X27 TRIAL RASP 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® - 00190361039259 Catalog Number :

Device Description : 21X27 TRIAL RASP 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® - 00190361039266 Catalog Number :

Device Description : 21X27 TRIAL RASP 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® - 00190361039273 Catalog Number :

Device Description : 21X27 TRIAL RASP 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® - 00190361039280 Catalog Number :

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

Device Class : 2

Duns Number: 002003243

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

Arena-L® - 00190361039297 Catalog Number :

Device Description : 21X27 TRIAL HEAD, ARENA-L ALLO, 8MM

Device Class : 2

Duns Number: 002003243

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

Arena-L® - 00190361039303 Catalog Number :

Device Description : 21X27 TRIAL HEAD, ARENA-L ALLO, 10MM

Device Class : 2

Duns Number: 002003243

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

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