Avatar Spinal System 114-082

GUDID 00819454010813

Pedicle Screw System

Life Spine, Inc.

Bone-screw internal spinal fixation system, non-sterile
Primary Device ID00819454010813
NIH Device Record Key2e6d0e1d-66c4-4c65-97d3-6d96957d4306
Commercial Distribution StatusIn Commercial Distribution
Brand NameAvatar Spinal System
Version Model Number114-082
Catalog Number114-082
Company DUNS183641617
Company NameLife Spine, Inc.
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
GS100819454010813 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NKBThoracolumbosacral pedicle screw system

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00819454010813]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-11-27
Device Publish Date2019-11-19

On-Brand Devices [Avatar Spinal System]

00819454010813Pedicle Screw System
00190837101749Beveled-Tip Jamshidi

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