"Lumbar Spacer System (SABRE, SHARK, HORNET, HARPOON)"

GUDID 00840996188609

PLI,SHAVER,PADDLE,QC,HUDSON,6

Choice Spine, LP

Polymeric spinal interbody fusion cage
Primary Device ID00840996188609
NIH Device Record Key7d8440d5-b641-44ec-8d09-1d58822181b1
Commercial Distribution StatusIn Commercial Distribution
Brand Name"Lumbar Spacer System (SABRE, SHARK, HORNET, HARPOON)"
Version Model NumberP070-2106
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
GS100840996188609 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LXHOrthopedic manual surgical instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840996188609]

Moist Heat or Steam Sterilization


[00840996188609]

Moist Heat or Steam Sterilization


[00840996188609]

Moist Heat or Steam Sterilization


[00840996188609]

Moist Heat or Steam Sterilization


[00840996188609]

Moist Heat or Steam Sterilization


[00840996188609]

Moist Heat or Steam Sterilization


[00840996188609]

Moist Heat or Steam Sterilization


[00840996188609]

Moist Heat or Steam Sterilization


[00840996188609]

Moist Heat or Steam Sterilization


[00840996188609]

Moist Heat or Steam Sterilization


[00840996188609]

Moist Heat or Steam Sterilization


[00840996188609]

Moist Heat or Steam Sterilization


[00840996188609]

Moist Heat or Steam Sterilization


[00840996188609]

Moist Heat or Steam Sterilization


[00840996188609]

Moist Heat or Steam Sterilization


[00840996188609]

Moist Heat or Steam Sterilization


[00840996188609]

Moist Heat or Steam Sterilization


[00840996188609]

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 ["Lumbar Spacer System (SABRE, SHARK, HORNET, HARPOON)"]

00840996188609PLI,SHAVER,PADDLE,QC,HUDSON,6
00840996188593PLI,SHAVER,PADDLE,QC,HUDSON,5
00840996188586PLI,SHAVER,PADDLE,QC,HUDSON,4

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