RELIANCE MEDICAL SYSTEMS, LLC

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

Appliance, Fixation, Spinal Interlaminal (KWP) (7) Appliance, Fixation, Spinal Intervertebral Body (KWQ) (7) Orthosis, Spinal Pedicle Fixation (MNI) (7) Orthosis, Spondylolisthesis Spinal Fixation (MNH) (7) Intervertebral Fusion Device With Bone Graft, Cervical (ODP) (3) Intervertebral Fusion Device With Integrated Fixation, Cervical (OVE) (3)

Premarket Exempt

Clear

Reliance PSS System - 00842566107072 Catalog Number : 6-45-CMIS35

Device Description : 4.5mm x 35mm Cann. MIS Poly. Screw, Ti

Device Class : 2

Duns Number: 064885444

Premarket Exempt : No

Product Code : MNH, KWP, KWQ, MNI

Prescription Use : Yes

Device Count : 1

Reliance PSS System - 00842566107089 Catalog Number : 6-45-CMIS40

Device Description : 4.5mm x 40mm Cann. MIS Poly. Screw, Ti

Device Class : 2

Duns Number: 064885444

Premarket Exempt : No

Product Code : MNH, KWP, KWQ, MNI

Prescription Use : Yes

Device Count : 1

Reliance PSS System - 00842566107096 Catalog Number : 6-45-CMIS45

Device Description : 4.5mm x 45mm Cann. MIS Poly. Screw, Ti

Device Class : 2

Duns Number: 064885444

Premarket Exempt : No

Product Code : MNH, KWP, KWQ, MNI

Prescription Use : Yes

Device Count : 1

Reliance PSS System - 00842566107126 Catalog Number : 6-04-004

Device Description : 14mm Hooked Open Rod Connector, Ti

Device Class : 2

Duns Number: 064885444

Premarket Exempt : No

Product Code : MNH, KWP, KWQ, MNI

Prescription Use : Yes

Device Count : 1

Reliance PSS System - 00842566107133 Catalog Number : 6-04-012

Device Description : 12mm Dual-Tulip Open Rod Connector, Ti

Device Class : 2

Duns Number: 064885444

Premarket Exempt : No

Product Code : MNH, KWP, KWQ, MNI

Prescription Use : Yes

Device Count : 1

Reliance PSS System - 00842566107140 Catalog Number : 6-04-014

Device Description : 14mm Dual-Tulip Open Rod Connector, Ti

Device Class : 2

Duns Number: 064885444

Premarket Exempt : No

Product Code : MNH, KWP, KWQ, MNI

Prescription Use : Yes

Device Count : 1

Reliance PSS System - 00842566107157 Catalog Number : 6-04-016

Device Description : 16mm Dual-Tulip Open Rod Connector, Ti

Device Class : 2

Duns Number: 064885444

Premarket Exempt : No

Product Code : KWP, KWQ, MNI, MNH

Prescription Use : Yes

Device Count : 1

Reliance Cervical IBF System - 00842566107553 Catalog Number : 1-02-004-HAG

Device Description : Cervical IBF-HA PEEK-STERILE, 14mm x 11mm x 4mm, 0°, PEEK OPTIMA LT1-HA

Device Class : 2

Duns Number: 064885444

Premarket Exempt : No

Product Code : OVE, ODP

Prescription Use : Yes

Device Count : 1

Reliance Cervical IBF System - 00842566107560 Catalog Number : 1-02-005--HAG

Device Description : Cervical IBF-HA PEEK-STERILE, 14mm x 11mm x 5mm, 0°, PEEK OPTIMA LT1-HA

Device Class : 2

Duns Number: 064885444

Premarket Exempt : No

Product Code : OVE, ODP

Prescription Use : Yes

Device Count : 1

Reliance Cervical IBF System - 00842566107577 Catalog Number : 1-02-006-HAG

Device Description : Cervical IBF-HA PEEK-STERILE, 14mm x 11mm x 6mm, 0°, PEEK OPTIMA LT1-HA

Device Class : 2

Duns Number: 064885444

Premarket Exempt : No

Product Code : ODP, OVE

Prescription Use : Yes

Device Count : 1

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