Neo/Kinetic 113-956

GUDID 00190837021016

SL Screw Remover Core

Life Spine, Inc.

Bone-screw internal spinal fixation system, non-sterile
Primary Device ID00190837021016
NIH Device Record Keyf1db1dbd-c353-442f-83c9-4184fc9ab01f
Commercial Distribution StatusIn Commercial Distribution
Brand NameNeo/Kinetic
Version Model Number113-956
Catalog Number113-956
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
GS100190837021016 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWQAppliance, fixation, spinal intervertebral body

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00190837021016]

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

Devices Manufactured by Life Spine, Inc.

00190837021016 - Neo/Kinetic2019-11-27SL Screw Remover Core
00190837021016 - Neo/Kinetic2019-11-27 SL Screw Remover Core
00190837026349 - PLATEAU Interbody, Straight, Bulleted, 10mm 28mm x 18mm, 0 Degree2019-11-27 PLATEAU Interbody, Straight, Bulleted, 10mm 28mm x 18mm, 0 Degree
00190837066123 - ProLift Expandable Spacer System2019-11-27 Expandable Cage Installer, Driver
00190837066154 - ProLift Expandable Spacer System2019-11-27 Paddle Distractor / Shaver, 6mm
00190837066192 - ProLift Expandable Spacer System2019-11-27 Paddle Distractor / Shaver, 10mm
00190837066208 - ProLift Expandable Spacer System2019-11-27 Paddle Distractor / Shaver, 11mm
00190837079239 - General Manual Instrument2019-11-27 T30 Driver
00190837081997 - Nautilus2019-11-27 Torque Limit 1/4 Inch Sq T-Handle, 80in-lb

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