XRL 03807367

GUDID H981038073670

XRL LARGE ENDPLATE FOOTPRINT TRIAL 27MM ROUND

SYNTHES (U.S.A.) LP

Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial

Primary Device ID	H981038073670
NIH Device Record Key	4c021880-be19-4bac-b55e-c56df69f867f
Commercial Distribution Status	In Commercial Distribution
Brand Name	XRL
Version Model Number	03.807.367
Catalog Number	03807367
Company DUNS	832637081
Company Name	SYNTHES (U.S.A.) LP
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Customer Support Contacts

Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	07611819406933 [Direct Marking]
GS1	10705034723358 [Primary]
HIBCC	H981038073670 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K103320

FDA Product Code

MQP	SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

Sterilization

Steralize Prior To Use	true
Device Is Sterile	false

[H981038073670]

Moist Heat or Steam Sterilization

[H981038073670]

Moist Heat or Steam Sterilization

[H981038073670]

Moist Heat or Steam Sterilization

[H981038073670]

Moist Heat or Steam Sterilization

[H981038073670]

Moist Heat or Steam Sterilization

[H981038073670]

Moist Heat or Steam Sterilization

[H981038073670]

Moist Heat or Steam Sterilization

[H981038073670]

Moist Heat or Steam Sterilization

[H981038073670]

Moist Heat or Steam Sterilization

[H981038073670]

Moist Heat or Steam Sterilization

[H981038073670]

Moist Heat or Steam Sterilization

[H981038073670]

Moist Heat or Steam Sterilization

[H981038073670]

Moist Heat or Steam Sterilization

[H981038073670]

Moist Heat or Steam Sterilization

[H981038073670]

Moist Heat or Steam Sterilization

[H981038073670]

Moist Heat or Steam Sterilization

[H981038073670]

Moist Heat or Steam Sterilization

[H981038073670]

Moist Heat or Steam Sterilization

[H981038073670]

Moist Heat or Steam Sterilization

[H981038073670]

Moist Heat or Steam Sterilization

[H981038073670]

Moist Heat or Steam Sterilization

[H981038073670]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	5
Public Version Date	2022-02-15
Device Publish Date	2015-09-14

On-Brand Devices [XRL]

H9810880730002S0	XRL LARGE ENDPLATE SCREWS- STERILE
H9810880720002S0	XRL MEDIUM ENDPLATE SCREWS- STERILE
H98108807345S0	XRL LARGE ENDPLATE 30MM X 40MM/20 DEG-STERILE
H98108807344S0	XRL LARGE ENDPLATE 30MM X 40MM/15 DEG-STERILE
H98108807343S0	XRL LARGE ENDPLATE 30MM X 40MM/10 DEG-STERILE
H98108807342S0	XRL LARGE ENDPLATE 30MM X 40MM/5 DEG-STERILE
H98108807341S0	XRL LARGE ENDPLATE 30MM X 40MM/0 DEG-STERILE
H98108807335S0	XRL LARGE ENDPLATE 28MM X 33MM/20 DEG-STERILE
H98108807334S0	XRL LARGE ENDPLATE 28MM X 33MM/15 DEG-STERILE
H98108807333S0	XRL LARGE ENDPLATE 28MM X 33MM/10 DEG-STERILE
H98108807332S0	XRL LARGE ENDPLATE 28MM X 33MM/5 DEG-STERILE
H98108807331S0	XRL LARGE ENDPLATE 28MM X 33MM/0 DEG-STERILE
H98108807325S0	XRL LARGE ENDPLATE 27MM ROUND/20 DEG-STERILE
H98108807324S0	XRL LARGE ENDPLATE 27MM ROUND/15 DEG-STERILE
H98108807323S0	XRL LARGE ENDPLATE 27MM ROUND/10 DEG-STERILE
H98108807322S0	XRL LARGE ENDPLATE 27MM ROUND/5 DEG-STERILE
H98108807321S0	XRL LARGE ENDPLATE 27MM ROUND/0 DEG-STERILE
H98108807315S0	XRL LARGE CENTRAL BODY 106MM-121MM HEIGHT-STERILE
H98108807314S0	XRL LARGE CENTRAL BODY 95MM-110MM HEIGHT-STERILE
H98108807313S0	XRL LARGE CENTRAL BODY 84MM-99MM HEIGHT-STERILE
H98108807312S0	XRL LARGE CENTRAL BODY 73MM-88MM HEIGHT-STERILE
H98108807311S0	XRL LARGE CENTRAL BODY 62MM-77MM HEIGHT-STERILE
H98108807310S0	XRL LARGE CENTRAL BODY 51MM-66MM HEIGHT-STERILE
H98108807309S0	XRL LARGE CENTRAL BODY 44MM-59MM HEIGHT-STERILE
H98108807308S0	XRL LARGE CENTRAL BODY 37MM-52MM HEIGHT-STERILE
H98108807307S0	XRL LARGE CENTRAL BODY 33MM-43MM HEIGHT-STERILE
H98108807306S0	XRL LARGE CENTRAL BODY 29MM-39MM HEIGHT-STERILE
H98108807305S0	XRL LARGE CENTRAL BODY 25MM-33MM HEIGHT-STERILE
H98108807304S0	XRL LARGE CENTRAL BODY 22MM-27MM HEIGHT-STERILE
H98108807303S0	XRL LARGE IMPLANT-INTEGRATED 29MM-37MM HEIGHT/0 DEG-STERILE
H98108807302S0	XRL LARGE IMPLANT-INTEGRATED 25MM-30MM HEIGHT/0 DEG-STERILE
H98108807301S0	XRL LARGE IMPLANT-INTEGRATED 23MM-26MM HEIGHT/0 DEG-STERILE
H98108807246S0	XRL MEDIUM ENDPLATE 26MM X 30MM/15 DEG-STERILE
H98108807245S0	XRL MEDIUM ENDPLATE 26MM X 30MM/10 DEG-STERILE
H98108807244S0	XRL MEDIUM ENDPLATE 26MM X 30MM/5 DEG-STERILE
H98108807243S0	XRL MEDIUM ENDPLATE 26MM X 30MM/0 DEG-STERILE
H98108807242S0	XRL MEDIUM ENDPLATE 26MM X 30MM/-5 DEG-STERILE
H98108807241S0	XRL MEDIUM ENDPLATE 26MM X 30MM/-10 DEG-STERILE
H98108807236S0	XRL MEDIUM ENDPLATE 21MM X 24MM/15 DEG-STERILE
H98108807235S0	XRL MEDIUM ENDPLATE 21MM X 24MM/10 DEG-STERILE
H98108807234S0	XRL MEDIUM ENDPLATE 21MM X 24MM/5 DEG-STERILE
H98108807233S0	XRL MEDIUM ENDPLATE 21MM X 24MM/0 DEG-STERILE
H98108807232S0	XRL MEDIUM ENDPLATE 21MM X 24MM/-5 DEG-STERILE
H98108807231S0	XRL MEDIUM ENDPLATE 21MM X 24MM/-10 DEG-STERILE
H98108807224S0	XRL MEDIUM ENDPLATE 21MM ROUND/15 DEG-STERILE
H98108807223S0	XRL MEDIUM ENDPLATE 21MM ROUND/10 DEG-STERILE
H98108807222S0	XRL MEDIUM ENDPLATE 21MM ROUND/5 DEG-STERILE
H98108807221S0	XRL MEDIUM ENDPLATE 21MM ROUND/0 DEG-STERILE
H98108807215S0	XRL MEDIUM CENTRAL BODY 106MM-121MM HEIGHT-STERILE
H98108807214S0	XRL MEDIUM CENTRAL BODY 95MM-110MM HEIGHT-STERILE

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