PERIMETER® Interbody Fusion Device

GUDID 00613994207012

SPACER 3494314 PRMTR XLG 8DEG 14MM

MEDTRONIC SOFAMOR DANEK, INC.

Polymeric spinal fusion cage, sterile Polymeric spinal fusion cage, sterile Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage
Primary Device ID00613994207012
NIH Device Record Key821b6452-5e9d-4f6b-ab96-b2857d931bd9
Commercial Distribution StatusIn Commercial Distribution
Brand NamePERIMETER® Interbody Fusion Device
Version Model Number3494314
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
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com

Device Dimensions

Length28 Millimeter
Length28 Millimeter
Length28 Millimeter
Length28 Millimeter
Length28 Millimeter
Length28 Millimeter
Length28 Millimeter
Length28 Millimeter
Width36 Millimeter
Height14 Millimeter
Angle8 degree
Length28 Millimeter
Width36 Millimeter
Height14 Millimeter
Angle8 degree
Length28 Millimeter
Width36 Millimeter
Height14 Millimeter
Angle8 degree
Length28 Millimeter
Width36 Millimeter
Height14 Millimeter
Angle8 degree
Length28 Millimeter
Width36 Millimeter
Height14 Millimeter
Angle8 degree
Length28 Millimeter
Width36 Millimeter
Height14 Millimeter
Angle8 degree
Length28 Millimeter
Width36 Millimeter
Height14 Millimeter
Angle8 degree
Length28 Millimeter
Width36 Millimeter
Height14 Millimeter
Angle8 degree
Length28 Millimeter
Width36 Millimeter
Height14 Millimeter
Angle8 degree
Length28 Millimeter
Width36 Millimeter
Height14 Millimeter
Angle8 degree
Length28 Millimeter
Width36 Millimeter
Height14 Millimeter
Angle8 degree
Length28 Millimeter
Width36 Millimeter
Height14 Millimeter
Angle8 degree
Length28 Millimeter
Width36 Millimeter
Height14 Millimeter
Angle8 degree
Length28 Millimeter
Width36 Millimeter
Height14 Millimeter
Angle8 degree
Length28 Millimeter
Width36 Millimeter
Height14 Millimeter
Angle8 degree
Length28 Millimeter
Width36 Millimeter
Height14 Millimeter
Angle8 degree
Length28 Millimeter
Width36 Millimeter
Height14 Millimeter
Angle8 degree
Length28 Millimeter
Width36 Millimeter
Height14 Millimeter
Angle8 degree
Length28 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100613994207012 [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 Number3
Public Version Date2018-07-06
Device Publish Date2015-08-18

On-Brand Devices [PERIMETER® Interbody Fusion Device]

00613994916341SPACER X0910108 PER TI LG 8D 30X12
00613994916334SPACER X0910109 PER TI LG 8D 30X14
00613994916327SPACER X0910110 PER TI LG 8D 30X16
00613994916310SPACER X0910111 PER TI LG 8D 30X18
00613994916303SPACER X0910112 PER TI LG 8D 30X20
00613994916297SPACER X0910113 PER TI LG 12D 30X8
00613994916280SPACER X0910114 PER TI LG 12D 30X10
00613994916273SPACER X0910115 PER TI LG 12D 30X12
00613994916266SPACER X0910116 PER TI LG 12D 30X14
00613994916259SPACER X0910117 PER TI LG 12D 30X16
00613994916242SPACER X0910118 PER TI LG 12D 30X18
00613994916235SPACER X0910119 PER TI LG 12D 30X20
00613994916228SPACER X0910120 PER TI XL 8D 36X8
00613994916211SPACER X0910121 PER TI XL 8D 36X10
00613994916204SPACER X0910122 PER TI XL 8D 36X12
00613994916198SPACER X0910107 PER TI LG 8D 30X10
00613994916181SPACER X0910092 PER TI MD 8D 26X8
00613994916174SPACER X0910093 PER TI MD 8D 26X10
00613994916167SPACER X0910094 PER TI MD 8D 26X12
00613994916150SPACER X0910095 PER TI MD 8D 26X14
00613994916143SPACER X0910096 PER TI MD 8D 26X16
00613994916136SPACER X0910097 PER TI MD 8D 26X18
00613994916129SPACER X0910098 PER TI MD 8D 26X20
00613994916112SPACER X0910099 PER TI MD 12D 26X8
00613994916105SPACER X0910100 PER TI MD 12D 26X10
00613994916099SPACER X0910101 PER TI MD 12D 26X12
00613994916082SPACER X0910102 PER TI MD 12D 26X14
00613994916075SPACER X0910103 PER TI MD 12D 26X16
00613994916068SPACER X0910104 PER TI MD 12D 26X18
00613994916051SPACER X0910105 PER TI MD 12D 26X20
00613994916044SPACER X0910106 PER TI LG 8D 30X8
00613994916037SPACER X1110073 PER TI XXL 8D 38X18
00613994916020SPACER X1110074 PER TI XXL 8D 38X20
00613994916013SPACER X1110075 PER TI XXL 12D 38X8
00613994916006SPACER X1110076 PER TI XXL 12D 38X10
00613994915993SPACER X1110077 PER TI XXL 12D 38X12
00613994915986SPACER X1110078 PER TI XXL 12D 38X14
00613994915979SPACER X1110079 PER TI XXL 12D 38X16
00613994915962SPACER X1110080 PER TI XXL 12D 38X18
00613994915955SPACER X1110081 PER TI XXL 12D 38X20
00613994915948SPACER X1110083 PER TI XXL 15D 38X10
00613994915931SPACER X1110084 PER TI XXL 15D 38X12
00613994915924SPACER X1110085 PER TI XXL 15D 38X14
00613994915917SPACER X1110086 PER TI XXL 15D 38X16
00613994915900SPACER X1110087 PER TI XXL 15D 38X18
00613994915894SPACER X1110088 PER TI XXL 15D 38X20
00613994915887SPACER X1110072 PER TI XXL 8D 38X16
00613994915870SPACER X0910123 PER TI XL 8D 36X14
00613994207043SPACER 3494320 PRMTR XLG 8DEG 20MM
00613994207036SPACER 3494318 PRMTR XLG 8DEG 18MM

Trademark Results [PERIMETER]

Mark Image

Registration | Serial
Company
Trademark
Application Date
PERIMETER
PERIMETER
98488476 not registered Live/Pending
Tyler Vision LLC
2024-04-08
PERIMETER
PERIMETER
90182949 not registered Live/Pending
Song, Dian
2020-09-15
PERIMETER
PERIMETER
88767043 not registered Live/Pending
Inteplast Group Corporation
2020-01-21
PERIMETER
PERIMETER
88189432 not registered Live/Pending
Ionotronics Corp.
2018-11-11
PERIMETER
PERIMETER
87324052 5361306 Live/Registered
ROSEN'S, INC.
2017-02-03
PERIMETER
PERIMETER
86938932 5492663 Live/Registered
Milliken & Company
2016-03-14
PERIMETER
PERIMETER
86926834 5036590 Live/Registered
Mind Head LLC
2016-03-02
PERIMETER
PERIMETER
85822820 4813243 Live/Registered
G-Form, LLC
2013-01-14
PERIMETER
PERIMETER
85753040 not registered Dead/Abandoned
Cloud Logix LLC
2012-10-12
PERIMETER
PERIMETER
85505651 4318256 Live/Registered
Fast Forward Brands, LLC
2011-12-29
PERIMETER
PERIMETER
85054256 not registered Dead/Abandoned
Perimeter Group LLC
2010-06-03
PERIMETER
PERIMETER
79012773 not registered Dead/Abandoned
Private Limited Company "K-D LAB"
2005-01-18
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.