Biogennix, LLC

Address:18009 Sky Park Cir Ste K,Irvine,CA,92614,US

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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

Sypher ALIF Spacer System - 00812593020002 Catalog Number : SAS-28241207

Device Description : Sypher Spacer - 28mm X 24mm X 12mm X 7°

Device Class : 2

Duns Number: 832270370

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

Sypher ALIF Spacer System - 00812593020019 Catalog Number : SAS-28241407

Device Description : Sypher Spacer - 28mm X 24mm X 14mm X 7°

Device Class : 2

Duns Number: 832270370

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

Sypher ALIF Spacer System - 00812593020026 Catalog Number : SAS-28241607

Device Description : Sypher Spacer - P/N 1239-103 - 28mm X 24mm X 16mm X 7°

Device Class : 2

Duns Number: 832270370

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

Sypher ALIF Spacer System - 00812593020033 Catalog Number : SAS-28241807

Device Description : Sypher Spacer - 28mm X 24mm X 18mm X 7°

Device Class : 2

Duns Number: 832270370

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

Sypher ALIF Spacer System - 00812593020040 Catalog Number : SAS-28241212

Device Description : Sypher Spacer - 28mm X 24mm X 12mm X 12°

Device Class : 2

Duns Number: 832270370

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

Sypher ALIF Spacer System - 00812593020057 Catalog Number : SAS-28241412

Device Description : Sypher Spacer - 28mm X 24mm X 14mm X 12°

Device Class : 2

Duns Number: 832270370

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

Sypher ALIF Spacer System - 00812593020064 Catalog Number : SAS-28241612

Device Description : Sypher Spacer - 28mm X 24mm X 16mm X 12°

Device Class : 2

Duns Number: 832270370

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

Sypher ALIF Spacer System - 00812593020071 Catalog Number : SAS-28241812

Device Description : Sypher Spacer - 28mm X 24mm X 18mm X 12°

Device Class : 2

Duns Number: 832270370

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

Sypher ALIF Spacer System - 00812593020088 Catalog Number : SAS-32261207

Device Description : Sypher Spacer - 32mm X 26mm X 12mm X 7°

Device Class : 2

Duns Number: 832270370

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

Sypher ALIF Spacer System - 00812593020095 Catalog Number : SAS-32261407

Device Description : Sypher Spacer - 32mm X 26mm X 14mm X 7°

Device Class : 2

Duns Number: 832270370

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

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