T2™ Spinal System

GUDID 00613994676498

CENTERPIECE 9391322 13 X 22MM 13C

MEDTRONIC SOFAMOR DANEK, INC.

Vertebral body prosthesis, non-sterile
Primary Device ID00613994676498
NIH Device Record Keyfe4994bd-0074-4271-9186-2b01bc932d1f
Commercial Distribution StatusIn Commercial Distribution
Brand NameT2™ Spinal System
Version Model Number9391322
Company DUNS830350380
Company NameMEDTRONIC SOFAMOR DANEK, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
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

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter13 Millimeter
Device Size Text, specify0
Outer Diameter13 Millimeter
Device Size Text, specify0
Outer Diameter13 Millimeter
Device Size Text, specify0
Outer Diameter13 Millimeter
Device Size Text, specify0
Outer Diameter13 Millimeter
Device Size Text, specify0
Outer Diameter13 Millimeter
Device Size Text, specify0
Outer Diameter13 Millimeter
Device Size Text, specify0
Outer Diameter13 Millimeter
Device Size Text, specify0
Outer Diameter13 Millimeter
Device Size Text, specify0
Outer Diameter13 Millimeter
Device Size Text, specify0
Outer Diameter13 Millimeter
Device Size Text, specify0
Outer Diameter13 Millimeter
Device Size Text, specify0
Outer Diameter13 Millimeter
Device Size Text, specify0
Outer Diameter13 Millimeter
Device Size Text, specify0
Outer Diameter13 Millimeter
Device Size Text, specify0
Outer Diameter13 Millimeter
Device Size Text, specify0
Outer Diameter13 Millimeter
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS100613994676498 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MQPSPINAL VERTEBRAL BODY REPLACEMENT DEVICE

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00613994676498]

Moist Heat or Steam Sterilization


[00613994676498]

Moist Heat or Steam Sterilization


[00613994676498]

Moist Heat or Steam Sterilization


[00613994676498]

Moist Heat or Steam Sterilization


[00613994676498]

Moist Heat or Steam Sterilization


[00613994676498]

Moist Heat or Steam Sterilization


[00613994676498]

Moist Heat or Steam Sterilization


[00613994676498]

Moist Heat or Steam Sterilization


[00613994676498]

Moist Heat or Steam Sterilization


[00613994676498]

Moist Heat or Steam Sterilization


[00613994676498]

Moist Heat or Steam Sterilization


[00613994676498]

Moist Heat or Steam Sterilization


[00613994676498]

Moist Heat or Steam Sterilization


[00613994676498]

Moist Heat or Steam Sterilization


[00613994676498]

Moist Heat or Steam Sterilization


[00613994676498]

Moist Heat or Steam Sterilization


[00613994676498]

Moist Heat or Steam Sterilization


[00613994676498]

Moist Heat or Steam Sterilization


[00613994676498]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-06-26

On-Brand Devices [T2™ Spinal System]

00613994676658CENTERPIECE 9391919 19 X 19MM 19A
00613994676641CENTERPIECE 9391923 19 X 23MM 19B
00613994676634CENTERPIECE 9391928 19 X 28MM 19C
00613994676627CENTERPIECE 9391936 19 X 36MM 19D
00613994676610CENTERPIECE 9391947 19 X 47MM 19E
00613994676603CENTERPIECE 9391969 19 X 69MM 19F
00613994676597CENTERPIECE 9392221 22 X 21MM 22A
00613994676580CENTERPIECE 9392225 22 X 25MM 22B
00613994676573CENTERPIECE 9392231 22 X 31MM 22C
00613994676566CENTERPIECE 9392237 22 X 37MM 22D
00613994676559CENTERPIECE 9392248 22 X 48MM 22E
00613994676542CENTERPIECE 9392268 22 X 68MM 22F
00613994676535CENTERPIECE 9391641 16 X 41MM 16F
00613994676511CENTERPIECE 9391316 13 X 16MM 13A
00613994676504CENTERPIECE 9391319 13 X 19MM 13B
00613994676498CENTERPIECE 9391322 13 X 22MM 13C
00613994676481CENTERPIECE 9391326 13 X 26MM 13D
00613994676474CENTERPIECE 9391332 13 X 32MM 13E
00613994676467CENTERPIECE 9391341 13 X 41MM 13F
00613994676450CENTERPIECE 9391617 16 X 17MM 16A
00613994676443CENTERPIECE 9391620 16 X 20MM 16B
00613994676436CENTERPIECE 9391623 16 X 23MM 16C
00613994676429CENTERPIECE 9391628 16 X 28MM 16D
00613994676412CENTERPIECE 9391633 16 X 33MM 16E
00613994676405CENTERPIECE 9392521 25 X 21MM 25A
00613994676399END CAP 9401900 19MM 0 DEGREE
00613994676382END CAP 9401904 19MM 4 DEGREE
00613994676375END CAP 9401908 19MM 8 DEGREE
00613994676368END CAP 9401915 19MM 15 DEGREE
00613994676351END CAP 9402200 22MM 0 DEGREE
00613994676344END CAP 9402204 22MM 4 DEGREE
00613994676337END CAP 9402208 22MM 8 DEGREE
00613994676320END CAP 9402215 22MM 15 DEGREE
00613994676313END CAP 9402500 25MM 0 DEGREE
00613994676306END CAP 9402504 25MM 4 DEGREE
00613994676290END CAP 9402508 25MM 8 DEGREE
00613994676283END CAP 9402515 25MM 15 DEGREE
00613994676276END CAP 9401615 16MM 15 DEGREE
00613994676269CENTERPIECE 9392525 25 X 25MM 25B
00613994676252CENTERPIECE 9392531 25 X 31MM 25C
00613994676245CENTERPIECE 9392537 25 X 37MM 25D
00613994676238CENTERPIECE 9392548 25 X 48MM 25E
00613994676221CENTERPIECE 9392568 25 X 68MM 25F
00613994676214END CAP 9401300 13MM 0 DEGREE
00613994676207END CAP 9401304 13MM 4 DEGREE
00613994676191END CAP 9401308 13MM 8 DEGREE
00613994676184END CAP 9401315 13MM 15 DEGREE
00613994676177END CAP 9401600 16MM 0 DEGREE
00613994676160END CAP 9401604 16MM 4 DEGREE
00613994676153END CAP 9401608 16MM 8 DEGREE

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