Silverbolt/Mainframe

GUDID 00840996170147

SILVERBOLT,SCREW,POLYAXIAL,6.5X25

Choice Spine, LP

Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile
Primary Device ID00840996170147
NIH Device Record Key0edc4457-9565-478e-8dc8-5550f7d5cb1c
Commercial Distribution StatusIn Commercial Distribution
Brand NameSilverbolt/Mainframe
Version Model Number200-2225
Company DUNS078293017
Company NameChoice Spine, LP
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
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

Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net

Device Dimensions

Length25 Millimeter
Outer Diameter6.5 Millimeter
Length25 Millimeter
Outer Diameter6.5 Millimeter
Length25 Millimeter
Outer Diameter6.5 Millimeter
Length25 Millimeter
Outer Diameter6.5 Millimeter
Length25 Millimeter
Outer Diameter6.5 Millimeter
Length25 Millimeter
Outer Diameter6.5 Millimeter
Length25 Millimeter
Outer Diameter6.5 Millimeter
Length25 Millimeter
Outer Diameter6.5 Millimeter
Length25 Millimeter
Outer Diameter6.5 Millimeter
Length25 Millimeter
Outer Diameter6.5 Millimeter
Length25 Millimeter
Outer Diameter6.5 Millimeter
Length25 Millimeter
Outer Diameter6.5 Millimeter
Length25 Millimeter
Outer Diameter6.5 Millimeter
Length25 Millimeter
Outer Diameter6.5 Millimeter
Length25 Millimeter
Outer Diameter6.5 Millimeter
Length25 Millimeter
Outer Diameter6.5 Millimeter
Length25 Millimeter
Outer Diameter6.5 Millimeter
Length25 Millimeter
Outer Diameter6.5 Millimeter
Length25 Millimeter
Outer Diameter6.5 Millimeter
Length25 Millimeter
Outer Diameter6.5 Millimeter
Length25 Millimeter
Outer Diameter6.5 Millimeter
Length25 Millimeter
Outer Diameter6.5 Millimeter
Length25 Millimeter
Outer Diameter6.5 Millimeter
Length25 Millimeter
Outer Diameter6.5 Millimeter
Length25 Millimeter
Outer Diameter6.5 Millimeter
Length25 Millimeter
Outer Diameter6.5 Millimeter
Length25 Millimeter
Outer Diameter6.5 Millimeter
Length25 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100840996170147 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MNHOrthosis, spondylolisthesis spinal fixation

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840996170147]

Moist Heat or Steam Sterilization

[00840996170147]

Moist Heat or Steam Sterilization

[00840996170147]

Moist Heat or Steam Sterilization

[00840996170147]

Moist Heat or Steam Sterilization

[00840996170147]

Moist Heat or Steam Sterilization

[00840996170147]

Moist Heat or Steam Sterilization

[00840996170147]

Moist Heat or Steam Sterilization

[00840996170147]

Moist Heat or Steam Sterilization

[00840996170147]

Moist Heat or Steam Sterilization

[00840996170147]

Moist Heat or Steam Sterilization

[00840996170147]

Moist Heat or Steam Sterilization

[00840996170147]

Moist Heat or Steam Sterilization

[00840996170147]

Moist Heat or Steam Sterilization

[00840996170147]

Moist Heat or Steam Sterilization

[00840996170147]

Moist Heat or Steam Sterilization

[00840996170147]

Moist Heat or Steam Sterilization

[00840996170147]

Moist Heat or Steam Sterilization

[00840996170147]

Moist Heat or Steam Sterilization

[00840996170147]

Moist Heat or Steam Sterilization

[00840996170147]

Moist Heat or Steam Sterilization

[00840996170147]

Moist Heat or Steam Sterilization

[00840996170147]

Moist Heat or Steam Sterilization

[00840996170147]

Moist Heat or Steam Sterilization

[00840996170147]

Moist Heat or Steam Sterilization

[00840996170147]

Moist Heat or Steam Sterilization

[00840996170147]

Moist Heat or Steam Sterilization

[00840996170147]

Moist Heat or Steam Sterilization

[00840996170147]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2018-02-18

On-Brand Devices [Silverbolt/Mainframe]

00840996175005SILVERBOLT,ML,ROD,STRAIGHT,TI,5.5X100
00840996174992SILVERBOLT,ML,ROD,STRAIGHT,TI,5.5X95
00840996174985SILVERBOLT,ML,ROD,STRAIGHT,TI,5.5X90
00840996174978SILVERBOLT,ML,ROD,STRAIGHT,TI,5.5X85
00840996174961SILVERBOLT,ML,ROD,STRAIGHT,TI,5.5X80
00840996174954SILVERBOLT,ML,ROD,STRAIGHT,TI,5.5X75
00840996174947SILVERBOLT,ML,ROD,STRAIGHT,TI,5.5X70
00840996174930SILVERBOLT,ML,ROD,STRAIGHT,TI,5.5X65
00840996170833SILVERBOLT,ROD,PREBENT,TI,5.5X95
00840996170819SILVERBOLT,SCREW,POLYAXIAL,5.5X80
00840996170802SILVERBOLT,SCREW,POLYAXIAL,5.5X75
00840996170796SILVERBOLT,SCREW,POLYAXIAL,5.5X70
00840996170789SILVERBOLT,SCREW,POLYAXIAL,5.5X65
00840996170772SILVERBOLT,SCREW,POLYAXIAL,5.5X60
00840996170765SILVERBOLT,SCREW,POLYAXIAL,5.5X25
00840996170192SILVERBOLT,SCREW,POLYAXIAL,6.5X80
00840996170185SILVERBOLT,SCREW,POLYAXIAL,6.5X75
00840996170178SILVERBOLT,SCREW,POLYAXIAL,6.5X70
00840996170161SILVERBOLT,SCREW,POLYAXIAL,6.5X65
00840996170154SILVERBOLT,SCREW,POLYAXIAL,6.5X30
00840996170147SILVERBOLT,SCREW,POLYAXIAL,6.5X25
00840996157483SILVERBOLT,CONNECTOR,42-58
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