Reliance Cervical IBF-S System 1-SW02-011

GUDID 00842566101988

Cervical IBF-SW, PEEK, 14x11, 0°, 11mm

RELIANCE MEDICAL SYSTEMS, LLC

Polymeric spinal interbody fusion cage
Primary Device ID00842566101988
NIH Device Record Key6793d2d7-4a12-46c7-a88c-2ce7d1e954f5
Commercial Distribution StatusIn Commercial Distribution
Brand NameReliance Cervical IBF-S System
Version Model Number1-SW02-011
Catalog Number1-SW02-011
Company DUNS064885444
Company NameRELIANCE MEDICAL SYSTEMS, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone801-295-3280
Emailinfo@reliance-medical.net
Phone801-295-3280
Emailinfo@reliance-medical.net
Phone801-295-3280
Emailinfo@reliance-medical.net
Phone801-295-3280
Emailinfo@reliance-medical.net
Phone801-295-3280
Emailinfo@reliance-medical.net
Phone801-295-3280
Emailinfo@reliance-medical.net
Phone801-295-3280
Emailinfo@reliance-medical.net
Phone801-295-3280
Emailinfo@reliance-medical.net
Phone801-295-3280
Emailinfo@reliance-medical.net
Phone801-295-3280
Emailinfo@reliance-medical.net
Phone801-295-3280
Emailinfo@reliance-medical.net
Phone801-295-3280
Emailinfo@reliance-medical.net
Phone801-295-3280
Emailinfo@reliance-medical.net
Phone801-295-3280
Emailinfo@reliance-medical.net
Phone801-295-3280
Emailinfo@reliance-medical.net
Phone801-295-3280
Emailinfo@reliance-medical.net
Phone801-295-3280
Emailinfo@reliance-medical.net
Phone801-295-3280
Emailinfo@reliance-medical.net

Device Identifiers

Device Issuing AgencyDevice ID
GS100842566101988 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MAXIntervertebral Fusion Device With Bone Graft, Lumbar
OVEIntervertebral Fusion Device With Integrated Fixation, Cervical

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00842566101988]

Moist Heat or Steam Sterilization

[00842566101988]

Moist Heat or Steam Sterilization

[00842566101988]

Moist Heat or Steam Sterilization

[00842566101988]

Moist Heat or Steam Sterilization

[00842566101988]

Moist Heat or Steam Sterilization

[00842566101988]

Moist Heat or Steam Sterilization

[00842566101988]

Moist Heat or Steam Sterilization

[00842566101988]

Moist Heat or Steam Sterilization

[00842566101988]

Moist Heat or Steam Sterilization

[00842566101988]

Moist Heat or Steam Sterilization

[00842566101988]

Moist Heat or Steam Sterilization

[00842566101988]

Moist Heat or Steam Sterilization

[00842566101988]

Moist Heat or Steam Sterilization

[00842566101988]

Moist Heat or Steam Sterilization

[00842566101988]

Moist Heat or Steam Sterilization

[00842566101988]

Moist Heat or Steam Sterilization

[00842566101988]

Moist Heat or Steam Sterilization

[00842566101988]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2020-02-24
Device Publish Date2016-12-09

On-Brand Devices [Reliance Cervical IBF-S System]

00842566102190Cervical IBF-S, Screw, Drilling Variable, 4.5, 20mm
00842566102183Cervical IBF-S, Screw, Drilling Variable, 4.5, 18mm
00842566102176Cervical IBF-S, Screw, Drilling Variable, 4.5, 16mm
00842566102169Cervical IBF-S, Screw, Drilling Variable, 4.5, 14mm
00842566102152Cervical IBF-S, Screw, Drilling Variable, 4.5, 12mm
00842566102145Cervical IBF-S, Screw, Drilling Variable, 4.5, 10mm
00842566102138Cervical IBF-S, Screw, Drilling Variable, 4.0, 20mm
00842566102121Cervical IBF-S, Screw, Drilling Variable, 4.0, 18mm
00842566102114Cervical IBF-S, Screw, Drilling Variable, 4.0, 16mm
00842566102107Cervical IBF-S, Screw, Drilling Variable, 4.0, 14mm
00842566102091Cervical IBF-S, Screw, Drilling Variable, 4.0, 12mm
00842566102084Cervical IBF-S, Screw, Drilling Variable, 4.0, 10mm
00842566102060Cervical IBF-SW, PEEK, 14x11, 7°, 11mm
00842566102053Cervical IBF-SW, PEEK, 14x11, 7°, 10mm
00842566102046Cervical IBF-SW, PEEK, 14x11, 7°, 9mm
00842566102039Cervical IBF-SW, PEEK, 14x11, 7°, 8mm
00842566102022Cervical IBF-SW, PEEK, 14x11, 7°, 7mm
00842566102015Cervical IBF-SW, PEEK, 14x11, 7°, 6mm
00842566102008Cervical IBF-SW, PEEK, 14x11, 7°, 5mm
00842566101995Cervical IBF-SW, PEEK, 14x11, 7°, 4mm
00842566101988Cervical IBF-SW, PEEK, 14x11, 0°, 11mm
00842566101971Cervical IBF-SW, PEEK, 14x11, 0°, 10mm
00842566101964Cervical IBF-SW, PEEK, 14x11, 0°, 9mm
00842566101957Cervical IBF-SW, PEEK, 14x11, 0°, 8mm
00842566101940Cervical IBF-SW, PEEK, 14x11, 0°, 7mm
00842566101933Cervical IBF-SW, PEEK, 14x11, 0°, 6mm
00842566101926Cervical IBF-SW, PEEK, 14x11, 0°, 5mm
00842566101919Cervical IBF-SW, PEEK, 14x11, 0°, 4mm
00842566101902Cervical IBF-SL, PEEK, 14x11, 7°, 11mm
00842566101896Cervical IBF-SL, PEEK, 14x11, 7°, 10mm
00842566101889Cervical IBF-SL, PEEK, 14x11, 7°, 9mm
00842566101872Cervical IBF-SL, PEEK, 14x11, 7°, 8mm
00842566101865Cervical IBF-SL, PEEK, 14x11, 7°, 7mm
00842566101858Cervical IBF-SL, PEEK, 14x11, 7°, 6mm
00842566101841Cervical IBF-SL, PEEK, 14x11, 7°, 5mm
00842566101834Cervical IBF-SL, PEEK, 14x11, 7°, 4mm
00842566101827Cervical IBF-SL, PEEK, 14x11, 0°, 11mm
00842566101810Cervical IBF-SL, PEEK, 14x11, 0°, 10mm
00842566101803Cervical IBF-SL, PEEK, 14x11, 0°, 9mm
00842566101797Cervical IBF-SL, PEEK, 14x11, 0°, 8mm
00842566101780Cervical IBF-SL, PEEK, 14x11, 0°, 7mm
00842566101773Cervical IBF-SL, PEEK, 14x11, 0°, 6mm
00842566101766Cervical IBF-SL, PEEK, 14x11, 0°, 5mm
00842566101759Cervical IBF-SL, PEEK, 14x11, 0°, 4mm
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