STERISPINE LC

GUDID 03760219910626

SAFE ORTHOPAEDICS

Metallic spinal interbody fusion cage
Primary Device ID03760219910626
NIH Device Record Keyd52d0a34-b0f5-49bf-9ca1-5aab3269eed3
Commercial Distribution StatusIn Commercial Distribution
Brand NameSTERISPINE LC
Version Model NumberKITLCS22-10
Company DUNS261875917
Company NameSAFE ORTHOPAEDICS
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS103760219910626 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MAXIntervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2020-03-27
Device Publish Date2015-10-13

On-Brand Devices [STERISPINE LC]

03760219912613KITLCS32-14
03760219912606KITLCS32-13
03760219912590KITLCS32-12
03760219912583KITLCS32-11
03760219912576KITLCS32-10
03760219912569KITLCS32-09
03760219912552KITLCS32-08
03760219912545KITLCS32-07
03760219912453KITLCC30-14
03760219912446KITLCC30-13
03760219912439KITLCC30-12
03760219912422KITLCC30-11
03760219912415KITLCC30-10
03760219912408KITLCC30-09
03760219912392KITLCC30-08
03760219912385KITLCC30-07
03760219910749KITLCS22-14
03760219910732KITLCS22-13
03760219910695KITLCS22-12
03760219910657KITLCS22-11
03760219910626KITLCS22-10
03760219910619KITLCS22-09
03760219910602KITLCS22-08
03760219910565KITLCS22-07
03760219910428KITLCS28-14
03760219910411KITLCS28-13
03760219910404KITLCS28-12
03760219910398KITLCS28-11
03760219910381KITLCS28-10
03760219910374KITLCS28-09
03760219910367KITLCS28-08
03760219910350KITLCS28-07
03760219913047KITANCLC 2
03760219910343KITANCLC
03760219919254KITLCS24-07
03760219919247KITLCS24-08
03760219919230KITLCS24-09
03760219919223KITLCS24-10
03760219919216KITLCS24-11
03760219919209KITLCS24-12
03760219919193KITLCS24-13
03760219919186KITLCS24-14
03760219919179KITLCS26-07
03760219919162KITLCS26-08
03760219919155KITLCS26-09
03760219919148KITLCS26-10
03760219919131KITLCS26-11
03760219919124KITLCS26-12
03760219919117KITLCS26-13
03760219919100KITLCS26-14

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