186310511

GUDID 10705034118604

SURGICAL TITANIUM MESH TRAPEZOID MESH 10 x (11 x 14) x 22mm

DEPUY SPINE, LLC

Metallic spinal fusion cage, non-sterile

Primary Device ID	10705034118604
NIH Device Record Key	360df1d0-47bf-4886-9c72-1f70d41f2734
Commercial Distribution Status	In Commercial Distribution
Version Model Number	186310511
Catalog Number	186310511
Company DUNS	107105876
Company Name	DEPUY SPINE, LLC
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	true
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
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	10705034118604 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K030249

FDA Product Code

MQP	SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

Sterilization

Steralize Prior To Use	true
Device Is Sterile	false

[10705034118604]

Moist Heat or Steam Sterilization

[10705034118604]

Moist Heat or Steam Sterilization

[10705034118604]

Moist Heat or Steam Sterilization

[10705034118604]

Moist Heat or Steam Sterilization

[10705034118604]

Moist Heat or Steam Sterilization

[10705034118604]

Moist Heat or Steam Sterilization

[10705034118604]

Moist Heat or Steam Sterilization

[10705034118604]

Moist Heat or Steam Sterilization

[10705034118604]

Moist Heat or Steam Sterilization

[10705034118604]

Moist Heat or Steam Sterilization

[10705034118604]

Moist Heat or Steam Sterilization

[10705034118604]

Moist Heat or Steam Sterilization

[10705034118604]

Moist Heat or Steam Sterilization

[10705034118604]

Moist Heat or Steam Sterilization

[10705034118604]

Moist Heat or Steam Sterilization

[10705034118604]

Moist Heat or Steam Sterilization

[10705034118604]

Moist Heat or Steam Sterilization

[10705034118604]

Moist Heat or Steam Sterilization

[10705034118604]

Moist Heat or Steam Sterilization

[10705034118604]

Moist Heat or Steam Sterilization

[10705034118604]

Moist Heat or Steam Sterilization

[10705034118604]

Moist Heat or Steam Sterilization

[10705034118604]

Moist Heat or Steam Sterilization

[10705034118604]

Moist Heat or Steam Sterilization

[10705034118604]

Moist Heat or Steam Sterilization

[10705034118604]

Moist Heat or Steam Sterilization

[10705034118604]

Moist Heat or Steam Sterilization

[10705034118604]

Moist Heat or Steam Sterilization

[10705034118604]

Moist Heat or Steam Sterilization

[10705034118604]

Moist Heat or Steam Sterilization

[10705034118604]

Moist Heat or Steam Sterilization

[10705034118604]

Moist Heat or Steam Sterilization

[10705034118604]

Moist Heat or Steam Sterilization

[10705034118604]

Moist Heat or Steam Sterilization

[10705034118604]

Moist Heat or Steam Sterilization

[10705034118604]

Moist Heat or Steam Sterilization

[10705034118604]

Moist Heat or Steam Sterilization

[10705034118604]

Moist Heat or Steam Sterilization

[10705034118604]

Moist Heat or Steam Sterilization

[10705034118604]

Moist Heat or Steam Sterilization

[10705034118604]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	4
Public Version Date	2019-11-06
Device Publish Date	2015-09-24

Devices Manufactured by DEPUY SPINE, LLC

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10705034579146 - N/A	2026-03-30 CUSTOM MADE DEVICE POLYAXIAL SCREW
10705034579153 - N/A	2026-03-30 CUSTOM MADE DEVICE POLYAXIAL SCREW
10705034579160 - N/A	2026-03-30 CUSTOM MADE DEVICE POLYAXIAL SCREW
10705034189727 - OCELOT	2026-03-25 OCELOT STACKABLE CAGE SYSTEM FILLER BLOCK
10705034190945 - ALIF	2026-03-25 UNIVERSAL ALIF INSTRUMENT SET DISC SHAVER 7 x 9mm
10705034192178 - MOSS	2026-03-25 MOSS MIAMI SPINE SYSTEM ROD APPROXIMATOR
10705034205090 - KEYSTONE	2026-03-25 KEYSTONE GRAFT DELIVERY INSTRUMENTS CPK GRABBER TIP CASSETTE 10/12/14mm

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