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 - 00812593020101 Catalog Number : SAS-32261607

Device Description : Sypher Spacer - 32mm X 26mm 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 - 00812593020118 Catalog Number : SAS-32261807

Device Description : Sypher Spacer - 32mm X 26mm 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 - 00812593020125 Catalog Number : SAS-32261212

Device Description : Sypher Spacer - 32mm X 26mm 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 - 00812593020132 Catalog Number : SAS-32261412

Device Description : Sypher Spacer - 32mm X 26mm 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 - 00812593020149 Catalog Number : SAS-32261612

Device Description : Sypher Spacer - 32mm X 26mm 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 - 00812593020156 Catalog Number : SAS-32261812

Device Description : Sypher Spacer - 32mm X 26mm 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 - 00812593020163 Catalog Number : SAS-35261207

Device Description : Sypher Spacer - 35mm 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 - 00812593020170 Catalog Number : SAS-35261407

Device Description : Sypher Spacer - 35mm X 26mm 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 - 00812593020187 Catalog Number : SAS-35261607

Device Description : Sypher Spacer - 35mm X 26mm 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 - 00812593020194 Catalog Number : SAS-35261807

Device Description : Sypher Spacer - 35mm X 26mm X 18mm X 7°

Device Class : 2

Duns Number: 832270370

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

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