Cranial Fusion Plate System 49-0812

GUDID 00190837068905

Rod Bender 7 1/2" For 4 & 3mm Rods

Life Spine, Inc.

Spinal fixation plate, non-bioabsorbable
Primary Device ID00190837068905
NIH Device Record Keyc81d7a88-d8e6-46a5-b7be-978359089a02
Commercial Distribution StatusIn Commercial Distribution
Brand NameCranial Fusion Plate System
Version Model Number49-0812
Catalog Number49-0812
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
GS100190837068905 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWPAPPLIANCE, FIXATION, SPINAL INTERLAMINAL

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00190837068905]

Moist Heat or Steam Sterilization


[00190837068905]

Moist Heat or Steam Sterilization


[00190837068905]

Moist Heat or Steam Sterilization


[00190837068905]

Moist Heat or Steam Sterilization


[00190837068905]

Moist Heat or Steam Sterilization


[00190837068905]

Moist Heat or Steam Sterilization


[00190837068905]

Moist Heat or Steam Sterilization


[00190837068905]

Moist Heat or Steam Sterilization


[00190837068905]

Moist Heat or Steam Sterilization


[00190837068905]

Moist Heat or Steam Sterilization


[00190837068905]

Moist Heat or Steam Sterilization


[00190837068905]

Moist Heat or Steam Sterilization


[00190837068905]

Moist Heat or Steam Sterilization


[00190837068905]

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 [Cranial Fusion Plate System]

00190837068936Tri-Cortical Allograft, 4cm
00190837068929Cranial Fusion Plate 35mm
00190837068912Cranial Fusion Plate 30mm
00190837068905Rod Bender 7 1/2" For 4 & 3mm Rods
00190837068899T15 Occipital Screwdriver
00190837068882Impact Sleeve
00190837068875Final Dilation Tube w/ Spikes
00190837068868OCT Adjustable Drill Guide, Slim
00190837068851Cranial Plate Caddy
00190837068844Cranial Plate Tab Bender
00190837068837Drill Stop
00190837068820Cranial Adjustable Drill Guide
00190837068813T15 Occipital Screwdriver
00190837068806114-314
00190837031404Set Screw
0019083703139840mm Plate
0019083703138135mm Plate
0019083703137430mm Plate

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