XRL 03807632

GUDID H981038076320

XRL LARGE TRIAL-ENDPLATE 28MM X 33MM/5 DEG

Synthes GmbH

Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial
Primary Device IDH981038076320
NIH Device Record Key39be5324-1d68-4eee-9653-0cf46223670c
Commercial Distribution StatusIn Commercial Distribution
Brand NameXRL
Version Model Number03.807.632
Catalog Number03807632
Company DUNS486711679
Company NameSynthes GmbH
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)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx

Device Identifiers

Device Issuing AgencyDevice ID
GS107611819407213 [Direct Marking]
GS110705034723969 [Primary]
HIBCCH981038076320 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MQPSPINAL VERTEBRAL BODY REPLACEMENT DEVICE

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[H981038076320]

Moist Heat or Steam Sterilization

[H981038076320]

Moist Heat or Steam Sterilization

[H981038076320]

Moist Heat or Steam Sterilization

[H981038076320]

Moist Heat or Steam Sterilization

[H981038076320]

Moist Heat or Steam Sterilization

[H981038076320]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2022-06-01
Device Publish Date2015-09-14

On-Brand Devices [XRL]

07611819406971XRL LARGE GRAFT PACKING PREPARATION TAMP
07611819406377XRL MEDIUM GRAFT PACKING PREPARATION TAMP
07611819406964XRL LARGE GRAFT PACKING TAMP
07611819406360XRL MEDIUM GRAFT PACKING TAMP
07611819419087XRL LARGE TORQUE LIMITING HANDLE
07611819419070XRL MEDIUM TORQUE LIMITING HANDLE
H981038073560XRL LARGE SPREADER TOP WITH 5MM DISTRACTION (INTEGRATED)
H981038073550XRL MEDIUM SPREADER TOP WITH 5MM DISTRACTION (INTEGRATED)
07611819406322XRL ENDPLATE REMOVAL TOOL
H981038073000XRL SPREADER
H981038076450XRL LARGE TRIAL-ENDPLATE 30MM X 40MM/20 DEG
H981038076440XRL LARGE TRIAL-ENDPLATE 30MM X 40MM/15 DEG
H981038076430XRL LARGE TRIAL-ENDPLATE 30MM X 40MM/10 DEG
H981038076420XRL LARGE TRIAL-ENDPLATE 30MM X 40MM/5 DEG
H981038076410XRL LARGE TRIAL-ENDPLATE 30MM X 40MM/0 DEG
H981038076350XRL LARGE TRIAL-ENDPLATE 28MM X 33MM/20 DEG
H981038076340XRL LARGE TRIAL-ENDPLATE 28MM X 33MM/15 DEG
H981038076330XRL LARGE TRIAL-ENDPLATE 28MM X 33MM/10 DEG
H981038076320XRL LARGE TRIAL-ENDPLATE 28MM X 33MM/5 DEG
H981038076310XRL LARGE TRIAL-ENDPLATE 28MM X 33MM/0 DEG
H981038076250XRL LARGE TRIAL-ENDPLATE 27MM ROUND/20 DEG
H981038076240XRL LARGE TRIAL-ENDPLATE 27MM ROUND/15 DEG
H981038076230XRL LARGE TRIAL-ENDPLATE 27MM ROUND/10 DEG
H981038076220XRL LARGE TRIAL-ENDPLATE 27MM ROUND/5 DEG
H981038076210XRL LARGE TRIAL-ENDPLATE 27MM ROUND/0 DEG
H981038076150XRL LARGE TRIAL-CENTRAL BODY 106MM-121MM HEIGHT
H981038076140XRL LARGE TRIAL-CENTRAL BODY 95MM-110MM HEIGHT
H981038076130XRL LARGE TRIAL-CENTRAL BODY 84MM-99MM HEIGHT
H981038076120XRL LARGE TRIAL-CENTRAL BODY 73MM-88MM HEIGHT
H981038076110XRL LARGE TRIAL-CENTRAL BODY 62MM-77MM HEIGHT
H981038076100XRL LARGE TRIAL-CENTRAL BODY 51MM-66MM HEIGHT
H981038076090XRL LARGE TRIAL-CENTRAL BODY 44MM-59MM HEIGHT
H981038076080XRL LARGE TRIAL-CENTRAL BODY 37MM-52MM HEIGHT
H981038076070XRL LARGE TRIAL-CENTRAL BODY 33MM-43MM HEIGHT
H981038076060XRL LARGE TRIAL-CENTRAL BODY 29MM-39MM HEIGHT
H981038076050XRL LARGE TRIAL-CENTRAL BODY 25MM-33MM HEIGHT
H981038076040XRL LARGE TRIAL-CENTRAL BODY 22MM-27MM HEIGHT
H981038076030XRL LARGE TRIAL-INTEGRATED 29MM-37MM HEIGHT/0 DEG
H981038076020XRL LARGE TRIAL-INTEGRATED 25MM-30MM HEIGHT/0 DEG
H981038076010XRL LARGE TRIAL-INTEGRATED 23MM-26MM HEIGHT/0 DEG
H981038075460XRL MEDIUM TRIAL-ENDPLATE 26MM X 30MM/15 DEG
H981038075450XRL MEDIUM TRIAL-ENDPLATE 26MM X 30MM/10 DEG
H981038075440XRL MEDIUM TRIAL-ENDPLATE 26MM X 30MM/5 DEG
H981038075430XRL MEDIUM TRIAL-ENDPLATE 26MM X 30MM/0 DEG
H981038075420XRL MEDIUM TRIAL-ENDPLATE 26MM X 30MM/-5 DEG
H981038075410XRL MEDIUM TRIAL-ENDPLATE 26MM X 30MM/-10 DEG
H981038075360XRL MEDIUM TRIAL-ENDPLATE 21MM X 24MM/15 DEG
H981038075350XRL MEDIUM TRIAL-ENDPLATE 21MM X 24MM/10 DEG
H981038075340XRL MEDIUM TRIAL-ENDPLATE 21MM X 24MM/5 DEG
H981038075330XRL MEDIUM TRIAL-ENDPLATE 21MM X 24MM/0 DEG
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