INTER FIX™ RP Threaded Fusion Device

GUDID 00673978957531

22X23 INTERFIXRP FUSION DEVICE

MEDTRONIC SOFAMOR DANEK, INC.

Metallic spinal interbody fusion cage
Primary Device ID00673978957531
NIH Device Record Key82b598fa-9efa-4692-b82d-e216a421cb21
Commercial Distribution StatusIn Commercial Distribution
Brand NameINTER FIX™ RP Threaded Fusion Device
Version Model Number9012223
Company DUNS830350380
Company NameMEDTRONIC SOFAMOR DANEK, 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 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

Customer Support Contacts

Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com

Device Dimensions

Outer Diameter22 Millimeter
Outer Diameter22 Millimeter
Outer Diameter22 Millimeter
Outer Diameter22 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100673978957531 [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 Number4
Public Version Date2020-02-24
Device Publish Date2014-09-23

On-Brand Devices [INTER FIX™ RP Threaded Fusion Device]

0067397895759324X29 INTERFIXRP FUSION DEVICE
0067397895758624X26 INTERFIXRP FUSION DEVICE
0067397895757924X23 INTERFIXRP FUSION DEVICE
0067397895756224X20 INTERFIXRP FUSION DEVICE
0067397895755522X29 INTERFIXRP FUSION DEVICE
0067397895754822X26 INTERFIXRP FUSION DEVICE
0067397895753122X23 INTERFIXRP FUSION DEVICE
0067397895752422X20 INTERFIXRP FUSION DEVICE
0067397895751720X29 INTERFIXRP FUSION DEVICE
0067397895750020X26 INTERFIXRP FUSION DEVICE
0067397895749420X23 INTERFIXRP FUSION DEVICE
0067397895748720X20 INTERFIXRP FUSION DEVICE
0067397895747018X29 INTERFIXRP FUSION DEVICE
0067397895746318X26 INTERFIXRP FUSION DEVICE
0067397895745618X23 INTERFIXRP FUSION DEVICE
0067397895744918X20 INTERFIXRP FUSION DEVICE
0067397895743216X29 INTERFIXRP FUSION DEVICE
0067397895742516X26 INTERFIXRP FUSION DEVICE
0067397895741816X23 INTERFIXRP FUSION DEVICE
0067397895740116X20 INTERFIXRP FUSION DEVICE
0067397895739514X29 INTERFIXRP FUSION DEVICE
0067397895738814X26 INTERFIXRP FUSION DEVICE
0067397895737114X23 INTERFIXRP FUSION DEVICE
0067397895736414X20 INTERFIXRP FUSION DEVICE
0067397895735712X25 INTERFIXRP FUSION DEVICE
0067397895734012X20 INTERFIXRP FUSION DEVICE

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