Silverbolt/Mainframe Instruments

GUDID 00840996187398

SILVERBOLT,TISSUE SPLIT BLD,(2)

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 ID00840996187398
NIH Device Record Key0078b906-bd53-40a7-814e-f4dd659af029
Commercial Distribution StatusIn Commercial Distribution
Brand NameSilverbolt/Mainframe Instruments
Version Model Number200-9703
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
GS100840996187398 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LXHOrthopedic manual surgical instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840996187398]

Moist Heat or Steam Sterilization


[00840996187398]

Moist Heat or Steam Sterilization


[00840996187398]

Moist Heat or Steam Sterilization


[00840996187398]

Moist Heat or Steam Sterilization


[00840996187398]

Moist Heat or Steam Sterilization


[00840996187398]

Moist Heat or Steam Sterilization


[00840996187398]

Moist Heat or Steam Sterilization


[00840996187398]

Moist Heat or Steam Sterilization


[00840996187398]

Moist Heat or Steam Sterilization


[00840996187398]

Moist Heat or Steam Sterilization


[00840996187398]

Moist Heat or Steam Sterilization


[00840996187398]

Moist Heat or Steam Sterilization


[00840996187398]

Moist Heat or Steam Sterilization


[00840996187398]

Moist Heat or Steam Sterilization


[00840996187398]

Moist Heat or Steam Sterilization


[00840996187398]

Moist Heat or Steam Sterilization


[00840996187398]

Moist Heat or Steam Sterilization


[00840996187398]

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/Mainframe Instruments]

00840996169233S'BOLT,DRIVER,POLY,SOLID,MAINFRAME
00840996169226S'BOLT,CANN,DR,POLY,MAINFRAME
00840996163576SILVERBOLT,TAP, W REAMER TIP, 7.0
00840996163569SILVERBOLT,TAP, W REAMER TIP, 6.0
00840996157469SILVERBOLT,DRIVER, X-15
00840996156615SILVERBOLT,ROD REDUCER
00840996187398SILVERBOLT,TISSUE SPLIT BLD,(2)
00840996181297SILVERBOLT, TAP, W REAMER, 5.5

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.