PERIMETER Spinal System

GUDID 00643169584051

TRIAL X1214494 PER XXL 15DEG 14MM

MEDTRONIC SOFAMOR DANEK, INC.

Spinal implant trial
Primary Device ID00643169584051
NIH Device Record Keya3553332-e3c4-4ddc-a76c-c78755486e5e
Commercial Distribution StatusIn Commercial Distribution
Brand NamePERIMETER Spinal System
Version Model NumberX1214494
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 Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
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

Device Dimensions

Angle15 degree
Angle15 degree
Angle15 degree
Angle15 degree
Angle15 degree
Angle15 degree
Angle15 degree
Angle15 degree
Width38 Millimeter
Height14 Millimeter
Length28 Millimeter
Angle15 degree
Width38 Millimeter
Height14 Millimeter
Length28 Millimeter
Angle15 degree
Width38 Millimeter
Height14 Millimeter
Length28 Millimeter
Angle15 degree
Width38 Millimeter
Height14 Millimeter
Length28 Millimeter
Angle15 degree
Width38 Millimeter
Height14 Millimeter
Length28 Millimeter
Angle15 degree
Width38 Millimeter
Height14 Millimeter
Length28 Millimeter
Angle15 degree
Width38 Millimeter
Height14 Millimeter
Length28 Millimeter
Angle15 degree
Width38 Millimeter
Height14 Millimeter
Length28 Millimeter
Angle15 degree
Width38 Millimeter
Height14 Millimeter
Length28 Millimeter
Angle15 degree
Width38 Millimeter
Height14 Millimeter
Length28 Millimeter
Angle15 degree
Width38 Millimeter
Height14 Millimeter
Length28 Millimeter
Angle15 degree

Device Identifiers

Device Issuing AgencyDevice ID
GS100643169584051 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MAXIntervertebral fusion device with bone graft, lumbar

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00643169584051]

Moist Heat or Steam Sterilization

[00643169584051]

Moist Heat or Steam Sterilization

[00643169584051]

Moist Heat or Steam Sterilization

[00643169584051]

Moist Heat or Steam Sterilization

[00643169584051]

Moist Heat or Steam Sterilization

[00643169584051]

Moist Heat or Steam Sterilization

[00643169584051]

Moist Heat or Steam Sterilization

[00643169584051]

Moist Heat or Steam Sterilization

[00643169584051]

Moist Heat or Steam Sterilization

[00643169584051]

Moist Heat or Steam Sterilization

[00643169584051]

Moist Heat or Steam Sterilization

[00643169584051]

Moist Heat or Steam Sterilization

[00643169584051]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-02-07
Device Publish Date2017-08-17

On-Brand Devices [PERIMETER Spinal System]

00643169585065SPACER X1214442 PER TI STER XXL 15 38X18
00643169585058SPACER X1214441 PER TI STER XXL 15 38X16
00643169585041SPACER X1214440 PER TI STER XXL 15 38X14
00643169585034SPACER X1214439 PER TI STER XXL 15 38X12
00643169585027SPACER X1214438 PER TI STER XXL 15 38X10
00643169585010SPACER X1214437 PER TI STER XXL 15D 38X8
00643169585003SPACER X1214436 PER TI STER XL 12D 36X20
00643169584990SPACER X1214435 PER TI STER XL 12D 36X18
00643169584983SPACER X1214434 PER TI STER XL 12D 36X16
00643169584976SPACER X1214433 PER TI STER XL 12D 36X14
00643169584969SPACER X1214432 PER TI STER XL 12D 36X12
00643169584952SPACER X1214431 PER TI STER XL 12D 36X10
00643169584938SPACER X1214429 PER TI STER XL 8D 36X20
00643169584921SPACER X1214428 PER TI STER XL 8D 36X18
00643169584914SPACER X1214427 PER TI STER XL 8D 36X16
00643169584907SPACER X1214426 PER TI STER XL 8D 36X14
00643169584891SPACER X1214425 PER TI STER XL 8D 36X12
00643169584884SPACER X1214424 PER TI STER XL 8D 36X10
00643169584860SPACER X1214422 PER TI STER LG 12D 30X20
00643169584853SPACER X1214421 PER TI STER LG 12D 30X18
00643169584846SPACER X1214420 PER TI STER LG 12D 30X16
00643169584839SPACER X1214419 PER TI STER LG 12D 30X14
00643169584822SPACER X1214418 PER TI STER LG 12D 30X12
00643169584815SPACER X1214417 PER TI STER LG 12D 30X10
00643169584792SPACER X1214415 PER TI STER LG 8D 30X20
00643169584785SPACER X1214414 PER TI STER LG 8D 30X18
00643169584778SPACER X1214413 PER TI STER LG 8D 30X16
00643169584761SPACER X1214412 PER TI STER LG 8D 30X14
00643169584754SPACER X1214411 PER TI STER LG 8D 30X12
00643169584747SPACER X1214410 PER TI STER LG 8D 30X10
00643169584723SPACER X1214408 PER TI STER MD 8D 26X20
00643169584716SPACER X1214407 PER TI STER MD 8D 26X18
00643169584709SPACER X1214406 PER TI STER MD 8D 26X16
00643169584693SPACER X1214405 PER TI STER MD 8D 26X14
00643169584686SPACER X1214404 PER TI STER MD 8D 26X12
00643169584679SPACER X1214403 PER TI STER MD 8D 26X10
00643169584082TRIAL X1214497 PER XXL 15DEG 20MM
00643169584075TRIAL X1214496 PER XXL 15DEG 18MM
00643169584068TRIAL X1214495 PER XXL 15DEG 16MM
00643169584051TRIAL X1214494 PER XXL 15DEG 14MM
00643169584044TRIAL X1214493 PER XXL 15DEG 12MM
00643169584037TRIAL X1214492 PER XXL 15DEG 10MM
00643169584020TRIAL X1214491 PER XL 12DEG 20MM
00643169584013TRIAL X1214490 PER XL 12DEG 18MM
00643169584006TRIAL X1214489 PER XL 12DEG 16MM
00643169583993TRIAL X1214488 PER XL 12DEG 14MM
00643169583986TRIAL X1214487 PER XL 12DEG 12MM
00643169583979TRIAL X1214486 PER XL 12DEG 10MM
00643169583955TRIAL X1214484 PER XL 8DEG 20MM
00643169583948TRIAL X1214483 PER XL 8DEG 18MM
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