Gruve Anterior Cervical Plate System

GUDID 00190837003814

Life Spine, Inc.

Bone-screw internal spinal fixation system, non-sterile
Primary Device ID00190837003814
NIH Device Record Key3b509bea-a584-4bec-99fd-574df09b45aa
Commercial Distribution StatusIn Commercial Distribution
Brand NameGruve Anterior Cervical Plate System
Version Model Number151-018
Company DUNS183641617
Company NameLife Spine, Inc.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
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
GS100190837003814 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWQAppliance, Fixation, Spinal Intervertebral Body

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00190837003814]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-06-08

On-Brand Devices [Gruve Anterior Cervical Plate System]

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001908370174221682-048
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001908370173781682-038
001908370173611682-036
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00190837003821152-010
00190837003814151-018
00190837003807151-016
00190837003791151-014
00190837003784151-012
00190837003777151-010

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