RELIANCE MEDICAL SYSTEMS, LLC

Address:545 West 500 South #100,Bountiful,UT,84010,US

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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) Intervertebral Fusion Device With Bone Graft, Cervical (ODP) (4) Intervertebral Fusion Device With Integrated Fixation, Cervical (OVE) (4)

Premarket Exempt

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Reliance Cervical IBF System - 00842566100462 Catalog Number : 1-03-707

Device Description : Cervical IBF PEEK, 16x14, 7mm, 7*

Device Class : 2

Duns Number: 064885444

Premarket Exempt : No

Product Code : ODP, OVE

Prescription Use : Yes

Device Count : 1

Reliance Cervical IBF System - 00842566100479 Catalog Number : 1-03-709

Device Description : Cervical IBF PEEK, 16x14, 9mm, 7*

Device Class : 2

Duns Number: 064885444

Premarket Exempt : No

Product Code : ODP, OVE

Prescription Use : Yes

Device Count : 1

Reliance Cervical IBF System - 00842566100486 Catalog Number : 1-03-710

Device Description : Cervical IBF PEEK, 16x14, 10mm, 7*

Device Class : 2

Duns Number: 064885444

Premarket Exempt : No

Product Code : OVE, ODP

Prescription Use : Yes

Device Count : 1

Reliance Cervical IBF System - 00842566100493 Catalog Number : 1-03-711

Device Description : Cervical IBF PEEK, 16x14, 11mm, 7*

Device Class : 2

Duns Number: 064885444

Premarket Exempt : No

Product Code : ODP, OVE

Prescription Use : Yes

Device Count : 1

Reliance Lumbar IBF System - 00842566100509 Catalog Number : 1-05-006

Device Description : Reliance IBF-VBS PEEK 10x26x6, 0°

Device Class : 2

Duns Number: 064885444

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

Reliance Lumbar IBF System - 00842566100516 Catalog Number : 1-05-007

Device Description : Reliance IBF-VBS PEEK 10x26x7, 0°

Device Class : 2

Duns Number: 064885444

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

Reliance Lumbar IBF System - 00842566100523 Catalog Number : 1-05-008

Device Description : Reliance IBF-VBS PEEK 10x26x8, 0°

Device Class : 2

Duns Number: 064885444

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

Reliance Lumbar IBF System - 00842566100530 Catalog Number : 1-05-009

Device Description : Reliance IBF-VBS PEEK 10x26x9, 0°

Device Class : 2

Duns Number: 064885444

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

Reliance Lumbar IBF System - 00842566100547 Catalog Number : 1-05-010

Device Description : Reliance IBF-VBS PEEK 10x26x10, 0°

Device Class : 2

Duns Number: 064885444

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

Reliance Lumbar IBF System - 00842566100554 Catalog Number : 1-05-011

Device Description : Reliance IBF-VBS PEEK 10x26x11, 0°

Device Class : 2

Duns Number: 064885444

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

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