SPINEOLOGY INC.

SPINEOLOGY INC.

Address:7800 THIRD STREET N.,Saint Paul,MN,55128,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

No

Clear

Duo Lumbar Interbody Fusion System - M7401001027 Catalog Number : 100-1027

Device Description : Duo Trial, 10mm, 8°

Device Class : 2

Duns Number: 033014361

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

Duo Lumbar Interbody Fusion System - M7401001028 Catalog Number : 100-1028

Device Description : Duo Trial, 12mm, 8°

Device Class : 2

Duns Number: 033014361

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

Duo Lumbar Interbody Fusion System - M7401001029 Catalog Number : 100-1029

Device Description : Duo Trial, 14mm, 8°

Device Class : 2

Duns Number: 033014361

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

Duo Lumbar Interbody Fusion System - M7401001030 Catalog Number : 100-1030

Device Description : Duo Trial, 16mm, 8°

Device Class : 2

Duns Number: 033014361

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

Elite Expandable Interbody Fusion System - M7401001054 Catalog Number : 100-1054

Device Description : Elite Inserter Fork

Device Class : 2

Duns Number: 033014361

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

Elite Expandable Interbody Fusion System - M7401001055 Catalog Number : 100-1055

Device Description : Elite Inserter Fork

Device Class : 2

Duns Number: 033014361

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

Elite Expandable Interbody Fusion System - M7401001073 Catalog Number : 100-1073

Device Description : Elite Inserter

Device Class : 2

Duns Number: 033014361

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

Elite Expandable Interbody Fusion System - M7401001095 Catalog Number : 100-1095

Device Description : Elite Short Handle Inserter

Device Class : 2

Duns Number: 033014361

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

Duo Lumbar Interbody Fusion System - M7401001112 Catalog Number : 100-1112

Device Description : Duo Straight Inserter Fork

Device Class : 2

Duns Number: 033014361

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

Duo Lumbar Interbody Fusion System - M7401001113 Catalog Number : 100-1113

Device Description : Duo Angled Inserter Fork

Device Class : 2

Duns Number: 033014361

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

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