WAVE D SPINAL SYSTEM

GUDID 00643169245341

THANDLE 2670011 T-HANDLE FOR DISTRACTOR

MEDTRONIC SOFAMOR DANEK, INC.

Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable
Primary Device ID00643169245341
NIH Device Record Key8842883c-3c98-4aff-8693-96e99c5a3164
Commercial Distribution StatusIn Commercial Distribution
Brand NameWAVE D SPINAL SYSTEM
Version Model Number2670011
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 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 Identifiers

Device Issuing AgencyDevice ID
GS100643169245341 [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

[00643169245341]

Moist Heat or Steam Sterilization

[00643169245341]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number6
Public Version Date2019-04-23
Device Publish Date2015-06-30

On-Brand Devices [WAVE D SPINAL SYSTEM]

00643169400535DISTRACTOR X0113137 WAVE D 6D 13X28
00643169400528DISTRACTOR X0113136 WAVE D 6D 12X28
00643169400511DISTRACTOR X0113135 WAVE D 6D 11X28
00643169400504DISTRACTOR X0113134 WAVE D 6D 10X28
00643169333956CAGE X0113133 WAVE D IB 6D 13X28
00643169333949CAGE X0113132 WAVE D IB 6D 12X28
00643169333932CAGE X0113131 WAVE D IB 6D 11X28
00643169333925CAGE X0113130 WAVE D IB 6D 10X28
00643169245419INSERTER 2670002 WAVE OUTER TUBE
00643169245402INSERTER 2670001 WAVE INNER TUBE
00643169245396DISTRACTOR 2671214 DSTCTR WAVE 14MM12DEG
00643169245389DISTRACTOR 2671213 DSTCTR WAVE 13MM12DEG
00643169245372CAP 2670015 WAVE IMPACTOR INSERTER CAP
00643169245358THANDLE 2670012 DISTRACTOR T-HANDLE LONG
00643169245341THANDLE 2670011 T-HANDLE FOR DISTRACTOR
00643169245310ROD 2670005 WAVE DISTRACTION ROD 28 MM
00643169245303ROD 2670004 WAVE DISTRACTION ROD 24 MM
00643169245297HANDLE 2670003 WAVE DISTRACTION HANDLE
00643169245280CAGE 2621324 WAVE D 13MM X 24MM 12DEG
00643169245273CAGE 2621424 WAVE D 14MM X 24MM 12DEG
00643169245266CAGE 2661424 WAVE D 14MM X 24MM 6DEG
00643169245259CAGE 2661324 WAVE D 13MM X 24MM 6DEG
00643169245242CAGE 2621224 WAVE D 12MM X 24MM 12DEG
00643169245235CAGE 2661224 WAVE D 12MM X 24MM 6DEG
00643169245228CAGE 2621124 WAVE D 11MM X 24MM 12DEG
00643169245211CAGE 2661124 WAVE D 11MM X 24MM 6DEG
00643169245204CAGE 2621024 WAVE D 10MM X 24MM 12DEG
00643169245198CAGE 2661024 WAVE D 10MM X 24MM 6DEG
00643169245181CAGE 2620924 WAVE D 9MM X 24MM 12DEG
00643169245174CAGE 2660924 WAVE D 9MM X 24MM 6DEG
00643169245167DISTRACTOR 2671212 DSTCTR WAVE 12MM12DEG
00643169245150DISTRACTOR 2671211 DSTCTR WAVE 11MM12DEG
00643169245143DISTRACTOR 2671210 DSTCTR WAVE 10MM12DEG
00643169245136DISTRACTOR 2671209 DSTCTR WAVE 9MM 12DEG
00643169245129DISTRACTOR 2670614 DSTCTR WAVE 14MM 6DEG
00643169245112DISTRACTOR 2670613 DSTCTR WAVE 13MM 6DEG
00643169245105DISTRACTOR 2670612 DSTCTR WAVE 12MM 6DEG
00643169245099DISTRACTOR 2670611 DSTCTR WAVE 11MM 6DEG
00643169245082DISTRACTOR 2670610 DSTCTR WAVE 10MM 6DEG
00643169245075DISTRACTOR 2670609 DSTCTR WAVE 9MM 6DEG
00643169245051PESTLE 2670008 WAVE PESTLE
00643169245044FUNNEL 2670007 WAVE FUNNEL
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