Silverbolt 2 Pedicle Screw System

GUDID 00840996187374

SILVERBOLT,GUIDEWIRES,NONSTERILE

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
Primary Device ID00840996187374
NIH Device Record Key55e48ba9-5438-46d3-aef1-66e68cd20dc4
Commercial Distribution StatusIn Commercial Distribution
Brand NameSilverbolt 2 Pedicle Screw System
Version Model Number200-9701
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 Usefalse
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100840996187374 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LXHOrthopedic manual surgical instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840996187374]

Moist Heat or Steam Sterilization


[00840996187374]

Moist Heat or Steam Sterilization


[00840996187374]

Moist Heat or Steam Sterilization


[00840996187374]

Moist Heat or Steam Sterilization


[00840996187374]

Moist Heat or Steam Sterilization


[00840996187374]

Moist Heat or Steam Sterilization


[00840996187374]

Moist Heat or Steam Sterilization


[00840996187374]

Moist Heat or Steam Sterilization


[00840996187374]

Moist Heat or Steam Sterilization


[00840996187374]

Moist Heat or Steam Sterilization


[00840996187374]

Moist Heat or Steam Sterilization


[00840996187374]

Moist Heat or Steam Sterilization


[00840996187374]

Moist Heat or Steam Sterilization


[00840996187374]

Moist Heat or Steam Sterilization


[00840996187374]

Moist Heat or Steam Sterilization


[00840996187374]

Moist Heat or Steam Sterilization


[00840996187374]

Moist Heat or Steam Sterilization


[00840996187374]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-07-14
Device Publish Date2023-07-06

On-Brand Devices [Silverbolt 2 Pedicle Screw System]

00840996160308SBOLT,TORQ HANDLE SQ DRV, 60 INLB
00840996187381SILVERBOLT,GUIDEWIRES,BLUNT,NONSTERILE
00840996187374SILVERBOLT,GUIDEWIRES,NONSTERILE

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