Neo-SL 113-650

GUDID 00190837036812

NEO SL 1-3 Level ACP Block

Life Spine, Inc.

Spinal fixation plate, non-bioabsorbable
Primary Device ID00190837036812
NIH Device Record Key87c2b357-7dc8-4ffe-b114-3d158f7dcbfe
Commercial Distribution StatusIn Commercial Distribution
Brand NameNeo-SL
Version Model Number113-650
Catalog Number113-650
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
GS100190837036812 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWQAppliance, fixation, spinal intervertebral body

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00190837036812]

Moist Heat or Steam Sterilization


[00190837036812]

Moist Heat or Steam Sterilization


[00190837036812]

Moist Heat or Steam Sterilization


[00190837036812]

Moist Heat or Steam Sterilization


[00190837036812]

Moist Heat or Steam Sterilization


[00190837036812]

Moist Heat or Steam Sterilization


[00190837036812]

Moist Heat or Steam Sterilization


[00190837036812]

Moist Heat or Steam Sterilization


[00190837036812]

Moist Heat or Steam Sterilization


[00190837036812]

Moist Heat or Steam Sterilization


[00190837036812]

Moist Heat or Steam Sterilization


[00190837036812]

Moist Heat or Steam Sterilization


[00190837036812]

Moist Heat or Steam Sterilization


[00190837036812]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-11-15
Device Publish Date2019-11-07

On-Brand Devices [Neo-SL]

0019083703687418mm Fixed Screw, D=4.3mm, SL-FT
0019083703686716mm Fixed Screw, D=4.3mm, SL-FT
0019083703685014mm Fixed Screw, D=4.3mm, SL-FT
0019083703684312mm Fixed Screw, D=4.3mm, SL-FT
00190837036836114-800
00190837036829114-011
00190837036812NEO SL 1-3 Level ACP Block

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