Gruve Anterior Cervical Plate System

GUDID 00190837004026

Life Spine, Inc.

Spinal fixation plate, non-bioabsorbable
Primary Device ID00190837004026
NIH Device Record Key4dd1020b-bd4b-4375-9eb8-dc6b4de74b4e
Commercial Distribution StatusIn Commercial Distribution
Brand NameGruve Anterior Cervical Plate System
Version Model Number1583-052
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
GS100190837004026 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWQAppliance, Fixation, Spinal Intervertebral Body

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00190837004026]

Moist Heat or Steam Sterilization


[00190837004026]

Moist Heat or Steam Sterilization


[00190837004026]

Moist Heat or Steam Sterilization


[00190837004026]

Moist Heat or Steam Sterilization


[00190837004026]

Moist Heat or Steam Sterilization


[00190837004026]

Moist Heat or Steam Sterilization


[00190837004026]

Moist Heat or Steam Sterilization


[00190837004026]

Moist Heat or Steam Sterilization


[00190837004026]

Moist Heat or Steam Sterilization


[00190837004026]

Moist Heat or Steam Sterilization


[00190837004026]

Moist Heat or Steam Sterilization


[00190837004026]

Moist Heat or Steam Sterilization


[00190837004026]

Moist Heat or Steam Sterilization


[00190837004026]

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]

001908370174461682-052
001908370174391682-050
001908370174221682-048
001908370174151682-046
001908370174081682-044
001908370173921682-042
001908370173851682-040
001908370173781682-038
001908370173611682-036
001908370173541682-034
001908370173471681-036
001908370173301681-034
001908370173231681-032
001908370173161681-030
001908370173091681-028
001908370172931681-026
001908370172861681-024
001908370172791681-022
001908370172621681-020
001908370040711583-067
001908370040641583-064
001908370040571583-061
001908370040401583-058
001908370040331583-055
001908370040261583-052
001908370040191582-046
001908370040021582-044
001908370039991582-042
001908370039821582-040
001908370039751582-038
001908370039681582-036
001908370039511581-028
001908370039441581-026
001908370039371581-024
001908370039201581-022
00190837003913153-018
00190837003906153-016
00190837003890153-014
00190837003883153-012
00190837003876153-010
00190837003869152-018
00190837003852152-016
00190837003845152-014
00190837003838152-012
00190837003821152-010
00190837003814151-018
00190837003807151-016
00190837003791151-014
00190837003784151-012
00190837003777151-010

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